[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-insomnia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-insomnia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,51,85,111,141,170,195,223,253,279,307,333,371,394,415,487,507,525,546,569,586,602,626,647,672],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625972","transcranial-alternating-current-stimulation-for-generalized-anxiety-disorder-and-insomnia-an-open-label-pilot-study-100625972",false,"NCT07429578","Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study","Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial","NewWaves","Inclusion Criteria:\n\nAge between 18 and 65 years; Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; Diagnosis of chronic primary insomnia; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score \\>5 on the Pittsburgh Sleep Quality Index (PSQI); Stable use of antidepressants (SSRI or SNRI) is allowed; Limited use of benzodiazepines (maximum of 10 mg\u002Fday diazepam equivalent).\n\nExclusion Criteria:\n\nHistory of mania, hypomania, or bipolar disorder; Contraindications to the use of transcranial stimulation; Active suicidal ideation or suicide attempt in the last 4 weeks; Refractoriness to 3 or more antidepressant treatments; Pregnancy; Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); Severe medical or neurological conditions; Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).","ALL","18 Years","65 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.",[28,29],"Generalized Anxiety Disorder (GAD)","Chronic Insomnia",[31,32,33,34,35,36,37],"tACS","Neuromodulation","Non-invasive brain stimulation","Sleep disorders","Anxiety treatment","Transcranial alternating current stimulation","Generalized Anxiety Disorder","RECRUITING","2026-06-19",{"date":41,"type":42},"2026-06-23","ACTUAL",{"date":44,"type":42},"2025-06-01",{"date":46,"type":22},"2026-07-31",{"name":48,"class":49},"University of Sao Paulo","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":50},"100634674","phase-4-a-smart-approach-to-evaluating-the-benefits-of-common-prescription-and-otc-medications-for-insomnia-100634674","NCT07542756","A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia","Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in Adults","Inclusion Criteria\n\n* Adults aged 18-80 years.\n* Meet DSM-5 criteria for Insomnia Disorder.\n* Score ≥15 on the Insomnia Severity Index (ISI).\n* Sleep initiation and\u002For maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights\u002Fweek, with a duration of ≥3 months.\n* Willingness to discontinue use of all sleep-related medications prior to enrollment.\n* Completion of a 2-week washout period before starting any study medication.\n* Willingness to provide clinician assent for participation.\n\nExclusion Criteria\n\nPatients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a history of suicidal attempts or current ideation, acute or chronic psychiatric or medical condition not controlled by therapy (according to their primary care physician), or current alcohol or drug misuse; or the diagnoses of (or high risk for) other sleep disorders, including circadian rhythm disorders (phase advance or phase delay syndromes), shift work related sleep disorder (\"day sleepers\" who work \\~11pm to 7am) and those with rotating shiftwork schedules. To determine eligibility, all subjects will be screened using a multitier process including: an online screener; an intake interview; a review of the subjects EMR; and, finally, the receipt of the patient's PCP's assent. The following provides additional listing and details (AD) for the Exclusion Criteria:\n\nGeneral Considerations\n\n* Age \\\u003C 18 or \\> 80 years old\n* Inadequate English language comprehension\n* Minimal facility with smartphones, computers, i-Pads, or the internet.\n\nWomen's Health Given the potential for teratogenic effects with at least trazodone (FDA Class C), women intending to become pregnant, or who are pregnant, or who are breastfeeding will not be eligible for the study. Women will be asked to confirm the use of birth control using self-report and, if applicable, by providing evidence of contraceptive medication (e.g., prescription or pill pack). We will perform a urine pregnancy test at baseline for female participants who are of reproductive age to confirm eligibility. At study enrollment, participants will be told to alert the study team and stop taking study medications if they become pregnant. Participants will be asked to test for pregnancy in the event of a missed cycle.\n\nMedical and Psychiatric Considerations\n\n* Acute or unstable psychiatric conditions\n* Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.\n* Significant liver or kidney problems\n* Pheochromocytoma or porphyria (contraindicated for trazodone)\n* Epilepsy or Seizure Disorder (contraindicated for trazodone)\n* Glaucoma or urinary retention (contraindicated for doxepin)\n* Increased ocular pressure (contraindicated for diphenhydramine)\n* Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit\n* Inability to refrain from drinking alcohol or substance use for at least 3 consecutive days\n\nSleep Disorders and Sleep Habits\n\n* Any lifetime history of (diagnosis of) breathing disorders, including COPD and sleep apnea.\n* Shift work related sleep disorder (work \\~11pm to 7am and \"day sleeper\") and rotating shiftwork schedules\n* Circadian rhythm disorders (phase advance or phase delay syndromes)\n* Self-reported usual daytime napping ≥1 hour per day (3 or more days per week)\n\nMedications and Concomitant meds\n\n* Known hypersensitivity or contraindication to study drugs\n* Known hypersensitivity or contraindication to drugs of the same class as the study treatments\n* Known hypersensitivity or contraindication to any excipients of the study drug formulation\n* Treatment with CNS active drugs prohibited by the protocol for five half-lives of the respective drug (or 2 weeks)\n\nLifestyle\n\n* Heavy tobacco use (≥1 pack of cigarettes a day or inability to refrain from smoking during the night)\n* Not able or willing to stop treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors","80 Years",{"count":60,"type":22},1200,[62],"PHASE4","The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk\u002Fbenefit profile (doxepin).",[65,66,29,67],"Insomnia","Insomnia Disorder","Chronic Insomnia Disorder",[69,65,70,71,72,73,74,75],"Sleep","Zolpidem","Diphenhydramine","Doxepin","Melatonin","Trazodone","Placebo","2026-06-04",{"date":78,"type":42},"2026-06-05",{"date":80,"type":42},"2026-05-01",{"date":82,"type":22},"2032-01-01",{"name":84,"class":49},"University of Pennsylvania",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":50},"100640363","effects-of-accelerated-rtms-on-sleep-architecture-in-chronic-insomnia-disorder-100640363","NCT07595185","Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder","Clinical and Neurophysiological Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder: A Prospective Pilot Study","Inclusion Criteria:\n\n* Subject must be 18 to 85 years of age, inclusive, on the day of signing informed consent.\n* Subject must meet DSM-5 criteria for insomnia disorder：\n\nA predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:\n\nDifficulty initiating sleep Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings Early-morning awakening with inability to return to sleep. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.\n\nThe sleep difficulty occurs at least 3 nights per week. The sleep difficulty is present for at least 3 months. The sleep difficulty occurs despite adequate opportunity for sleep. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (eg, narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).\n\nThe insomnia is not attributable to the physiological effects of a substance (eg, a drug of abuse, a medication).\n\nCoexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.\n\n* Subject must have an ISI total score ≥15 at screening.\n* Subject must have an sSOL ≥45 minutes and an sWASO ≥60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the CSD-M, prior to screening Somfit™ sleep test assessments.\n* Subject must demonstrate a 2-night mean SOL of ≥25 minutes (with neither night \\\u003C20 minutes), a 2-night mean WASO ≥30 minutes, and a 2-night mean TST ≤6.5 hours, with neither night \\>7 hours.\n* Subject must be otherwise healthy or present with stable, well-controlled, chronic conditions on the basis of physical examination, medical history, vital signs, 12-lead ECG (if necessary), and clinical laboratory tests (if necessary) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. If the results of the clinical laboratory tests are outside the normal reference ranges, the subject may be included only if the investigator and the sponsor's Safety Physician judge the abnormality or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initiated by the investigator.\n* Body mass index between 18 and 35 kg\u002Fm2 inclusive (body mass index = weight\u002Fheight\\^2).\n* For subjects ≥65 years of age, a Mini-Mental State Examination score of ≥25 to rule out cognitive impairment in the interest of subject safety.\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in sleep quality and reduction of stress, including non-invasive brain stimulation treatments other than the study procedure during study participation.\n* Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation.\n* Willingness to comply with study instructions and to return to the clinic for the required visits.\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.\n* If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry.\n* Subject is not using any sleeping medication or is using over-the-counter pills (except Valerian and St. John's Wort) no more than 4 times a week.\n* Subject must usually spend between 6 and 9 hours in bed during the night and go to bed between 8 PM and 1 AM and typically get out of bed between 5 AM and 9 AM.\n* Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Subjects must sign a separate ICF if he or she agrees to provide an optional DNA sample for research (where local regulations permit). Refusal to give consent for the optional DNA research samples does not exclude a subject from participation in the study.\n\nExclusion Criteria:\n\n* Has history of or current clinically significant and\u002For unstable liver (moderate or severe hepatic impairment \\[Child-Pugh Score ≥7\\]) or renal insufficiency (severe renal impairment \\[estimated creatinine clearance below 30 mL\u002Fmin\\]; serum creatinine \\>2 mg\u002FdL); significant and\u002For unstable cardiac, vascular, pulmonary (eg, acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (eg, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study (eg, medically frail subject with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary.\n\nNote: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator and the sponsor's Safety Physician.\n\n* Has uncontrolled hypertension (supine systolic blood pressure \\>150 mm Hg in adult subjects or \\>160 mm Hg in elderly subjects or supine diastolic blood pressure \\>90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy) at screening or Day 1. (A subject with hypertension may be included if the subject's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months).\n* Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c \\[HbA1c\\] ≤8%) may be eligible to participate if otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor's Safety Physician, are acceptable.\n* Has clinically significant ECG abnormalities at screening or Day 1 prior to treatment defined as:\n\nT interval corrected according to Fridericia's formula: ≥450 msec (males);\n\n≥470 msec (females). Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \\>210 msec, left bundle branch block.\n\nFeatures of new ischemia. Other clinically important arrhythmia. Note: Subjects with right bundle branch block may be allowed provided confirmation that right bundle branch block is not associated with underlying cardiac\u002Flung diseases.\n\n* Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.\n* Metallic, ferromagnetic or other magnetic-sensitive implants\u002Fobjects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 in (30 cm) of the therapy coil. (Examples include implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes and tattoos with metallic ink), drug pumps (within 12 in (30 cm) of the therapy coil) application in the heart area.\n* Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator).\n* Moderate-to-severe obstructive sleep apnea (AHI ≥15 events\u002Fhour) that is untreated or inadequately controlled (residual AHI ≥5 events\u002Fhour on CPAP therapy).\n* Regularly naps more than 3 times per week.\n* Has a current diagnosis or recent history of psychotic disorder, MDD, bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.\n* Has a current or recent history of serious suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year. Subjects with a prior suicide attempt of any sort, or prior serious suicidal ideation\u002Fplan within the past 6 months, should be carefully screened for current suicidal ideation and only subjects with non-serious items may be included at the discretion of the investigator.\n* Has insomnia related to RLS (defined as PLM-arousal index of ≥10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult subjects or \\>15 for elderly subjects), sleep breathing disorder (defined as an apnea-hypopnea index ≥10 cumulative apneas and hypopneas per hour of EEG sleep for adult subjects or \\>15 for elderly subjects), or parasomnias. These disorders will be ruled out by the first PSG recording during Part 2 of screening.\n* Is a shift worker or has a significantly shifted diurnal activity pattern.\n* Has experienced transmeridian travel across 2 or more time zones within the 2 weeks prior to screening, or plans to travel across 2 or more time zones during study participation.\n* Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with the concurrence with the sponsor's Safety Physician, is considered cured with minimal risk of recurrence).\n* Has a history of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates \\[including methadone\\], cocaine, cannabinoids, methamphetamines, amphetamines, 3,4-Methylenedioxymethamphetamine, and BZD) at screening or at baseline.\n* Smokes \\>10 cigarettes per day and\u002For has quit smoking within 1 month prior to screening.\n* Consumes \\>500 mg of caffeine per day in any form (tea\u002Fcoffee\u002Fcocoa\u002Fcola\u002Fenergy drinks) averagely. Refer to caffeineinformer.com\u002Fthe-caffeine-database for average caffeine content of various beverages.\n* Had clinically significant acute illness within 7 days prior to study rTMS treatment.\n* Is under ongoing psychological treatments focused on insomnia (eg, Cognitive Behavior Therapy), initiated within 2 months prior to Day 1. A subject who has been receiving ongoing psychological treatment for a period of greater than 2 months is eligible, if the investigator deems the psychological treatment to be of stable duration and frequency. The subject's psychological treatment should be maintained during participation in the study.\n* Has donated 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 60 days prior to study.\n* Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.\n* Has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or is currently enrolled in an investigational study.\n* Has psychologic and\u002For emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements, or is a vulnerable subject due to involuntary detention (such as for legal reasons).\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Has had major surgery, (eg, requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n* Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.","85 Years",{"count":94,"type":22},70,[25],"Chronic insomnia disorder is a common condition in which people have ongoing difficulty falling asleep, staying asleep, or waking too early. It affects about 10-12% of adults and can lead to daytime problems, stress, and other health issues. Current treatments include talk therapy (cognitive behavioral therapy for insomnia) and sleep medications, but medications can have side effects and may not work well over the long term.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses applied to the scalp to stimulate specific areas of the brain. It has shown promise in improving sleep quality in people with insomnia by targeting a brain region called the left dorsolateral prefrontal cortex, which plays a role in the overactive brain arousal thought to cause insomnia.\n\nThe purpose of this study is to find out whether an accelerated course of rTMS using the EXOMIND™ device can improve sleep in adults with chronic insomnia disorder. The study will enroll approximately 70 participants aged 18 to 85 years at a single site in San Francisco. Participants will receive 6 rTMS sessions (3 times per week for 2 weeks). Each session lasts about 25 minutes.\n\nThe study has three phases: a screening phase (up to 25 days) to confirm eligibility using sleep questionnaires and at-home sleep monitoring, a 2-week open-label treatment phase, and a follow-up phase with visits at 1 month and 3 months after the last treatment session. Total participation lasts up to approximately 139 days.\n\nThe main goal is to measure whether insomnia severity improves after treatment, using a standard questionnaire called the Insomnia Severity Index (ISI). The study will also measure changes in objective sleep patterns (such as how long it takes to fall asleep, time spent in deep sleep, and total sleep time) recorded by a home sleep monitoring device, as well as changes in sleep quality, stress levels, and overall clinical impression of improvement.\n\nThis is an open-label pilot study, meaning all participants will receive the rTMS treatment and there is no placebo group. The study does not involve any medications. Participants must not have certain medical conditions, electronic or metal implants in or near the head, untreated sleep apnea, or active serious psychiatric disorders. Participants who are pregnant or breastfeeding cannot take part.",[65,29,67,98],"Sleep Disturbance",[100,67,65],"Sleep Efficiency","NOT_YET_RECRUITING","2026-05-12",{"date":104,"type":42},"2026-05-19",{"date":106,"type":22},"2026-05-20",{"date":108,"type":22},"2028-06-30",{"name":110,"class":49},"San Francisco Neurology and Sleep Center",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":50},"100609567","implementing-cognitive-behavioral-therapy-for-insomnia-swell-function-queri-30-100609567","NCT07216261","Implementing Cognitive Behavioral Therapy for Insomnia (SWELL): Function QUERI 3.0","Implementing Cognitive Behavioral Therapy for Insomnia With Older Veterans: Function QUERI 3.0 (QUE 25-008)","SWELL","Inclusion Criteria:\n\nSite Inclusion Criteria:\n\n* Facility is part of the U.S. Department of Veterans Affairs (VA) health system.\n* Primary care clinic providing care to older Veterans\n* Clinic is located 25 miles from the nearest other VA clinic participating in the program\n* Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.\n\nPatient Inclusion Criteria:\n\n* meet diagnostic criteria for chronic insomnia disorder (with or without documented diagnosis)\n* absence of a CBTI contraindication oi.e., comorbid condition that makes CBTI unsafe), including uncontrolled seizure disorders, bipolar disorder I, and\u002For too medically or psychiatrically unstable to engage in a multi-session treatment opatients can be referred to SWELL by a clinician or self-referred\n\nExclusion Criteria:\n\nSite Exclusion Criteria:\n\n* No members of the SWELL team working in the clinic\n\nPatient Exclusion Criteria:\n\n* younger than 60\n* do not meet criteria for enrollment","60 Years",{"count":121,"type":22},20,[25],"Implementing Cognitive Behavioral Therapy for Insomnia with Older Veterans (SWELL): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effectiveness of the EBP in its new context. The overall goal is to implement, evaluate, and sustain SWELL in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.",[29],[126,127,128,129,130,131],"Sleep Disorders","Implementation Science","Functional Status","Quality of Life","Cognitive Behavioral Therapy","Veterans",{"date":133,"type":42},"2026-05-07",{"date":135,"type":42},"2026-04-30",{"date":137,"type":22},"2030-09-30",{"name":139,"class":140},"VA Office of Research and Development","FED",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":148,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":4},"100635039","prediction-of-different-variants-of-sleep-stages-for-the-diagnosis-support-of-chronic-insomnia-and-epilepsy-100635039","NCT07547501","PREDiction of Different Variants of Sleep Stages for the Diagnosis Support of Chronic Insomnia and Epilepsy","PREDSomADICE","Inclusion Criteria\n\n* Patients with chronic insomnia and\u002For epilepsy who underwent polysomnography in a neurophysiology or neurology setting under the responsibility of Pr Navarro between 01 September 2011 and 31 December 2024.\n* Age ≥18 and ≤65 years at the time of the polysomnography recording.\n\nExclusion Criteria\n\n* Severe psychiatric disorder, including decompensated psychotic disorder, manic episode, or major depressive episode with melancholic features.\n* Use of continuous positive airway pressure (CPAP) therapy during the night of recording.\n* Patient refusal or documented opposition to data use.",{"count":149,"type":22},1500,"OBSERVATIONAL","The objective of this study is to develop and validate deep learning algorithms for automated sleep stage and sub-stage classification using overnight polysomnography data. The models will be trained and evaluated on at least three independent datasets to ensure generalizability.\n\n\\- Primary Outcome Measure : Accuracy of deep learning-based sleep stage classification compared to expert manual scoring (\\>80% target agreement), evaluated across multiple polysomnography datasets including AP-HP (Assistance Publique - Hôpitaux de Paris) data.\n\nThis is a retrospective, observational study.",[29,153,126],"Epilepsy",[155,156,157,158,159,34,160,153],"Sleep staging","Polysomnography","EEG","Deep learning","Artificial intelligence","Chronic insomnia","2026-04-23",{"date":163,"type":42},"2026-04-29",{"date":165,"type":22},"2026-06",{"date":167,"type":22},"2027-03",{"name":169,"class":49},"Assistance Publique - Hôpitaux de Paris",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":50},"100604966","restorative-effects-of-sleep-on-everyday-health-and-wellbeing-a-treatment-study-100604966","NCT07156383","Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study","Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia","RESET","Inclusion Criteria:\n\n* At least 18-years-old\n* Speaks English\n* Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)\n\nExclusion Criteria:\n\n* Sleep disorders other than Insomnia\n* Endocrine disorders\n* Extreme sleep schedule (i.e. shift workers)\n* Currently taking sleep medication\n* Currently taking medication for endocrine dysfunction\n* Currently taking medication that interferes with sleep or cortisol levels\n* Excessive alcohol\u002Fsubstance use or AUD\u002FSUD\n* Serious mental illness\n* Chronic medical conditions (which may be exacerbated by sleep restriction)\n* Pregnant or nursing women\n* Women in the peri-menopausal stage due to irregular menses and fluctuations in sex hormones.",{"count":179,"type":22},115,[25],"The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. The primary research aims are: 1) To determine whether changes in cortisol functioning are related to improvements in sleep consolidation (4-week CBT-I), sleep duration (10-week CBT-I) or both, AND 2) to examine whether these improvements are more pronounced among individuals with insomnia and short sleep duration (compared to insomnia with 'normal' sleep duration).This study will recruit individuals with chronic insomnia: half with reported short sleep duration (less than 6 hours of sleep on an average night) and half with reported non-short sleep duration (6 or more hours per night). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.",[29],[184,66,126,185,186],"Sleep Initiation and Maintenance Disorders","Cortisol","Sleep Deprivation","2026-04-20",{"date":161,"type":42},{"date":190,"type":42},"2025-09-29",{"date":192,"type":22},"2027-08-31",{"name":194,"class":49},"University of Notre Dame",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":50},"100542669","improving-sleep-and-reducing-opioid-use-in-individuals-with-chronic-pain-100542669","NCT06345872","Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain","SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain","Inclusion Criteria:\n\n* 18+ yrs\n* willing to be randomized,\n* can read\u002Funderstand English\n* diagnosed with chronic widespread pain and insomnia (as described below)\n* prescribed opioid medication for 1+ mo, 3+ times per week\n* desire to reduce or eliminate opioid use\n* written agreement from physician prescribing opioid medication\n* no prescribed or OTC sleep meds for 1+ mo, or stabilized on meds for 6+ wks\n\nExclusion Criteria:\n\n* unable to provide informed consent\n* cognitive impairment (MMSE \\\u003C26)\n* sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea index, AHI \\>15)\n* Periodic Limb Movement Disorder (myoclonus arousals per hour \\>15)\\]\n* bipolar or seizure disorder (due to risk of sleep restriction treatment)\n* other severe, untreated major psychopathology except for depression or anxiety (e.g.,suicidal ideation\u002Fintent, psychotic disorders)\n* psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)\n* participation in other non-pharmacological treatment for pain, sleep, or mood outside the current trial\n* internal metal objects or electrical devices\n* pregnancy\n* presumptive\u002Fconfirmed lumbar nerve root compression\n* confirmed lumbar spinal stenosis\n* \\\u003C6 mos post-back surgery\n* other spinal disorders",true,{"count":204,"type":22},165,[25],"The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.",[208,29,209],"Chronic Pain","Opioid Use",[211,160,212,213],"Chronic pain","Opioid use","CBT-I","2026-04-17",{"date":216,"type":42},"2026-04-21",{"date":218,"type":42},"2024-12-11",{"date":220,"type":22},"2028-07-01",{"name":222,"class":49},"University of South Florida",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":50},"100596679","brief-trial-of-act-i-for-adults-with-chronic-insomnia-100596679","NCT07048600","Brief Trial of ACT-i for Adults With Chronic Insomnia","Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* clinical\u002F subclinical diagnosis of chronic insomnia either already diagnosed by a professional, or identified with SCISD-R by our team of clinicians\n* age over 18 and older, but not over 59 years old;\n* minimal\u002F mild symptomatology of depression (scores ≤ 9 on PHQ-9) and\u002F or anxiety (scores ≤ 9 on GAD-7) or as diagnosed with SCID-5-CV;\n\nExclusion Criteria:\n\n* diagnosed with a neurological degenerative disorder, or any moderate\u002F severe psychiatric disorder;\n* diagnosed with other sleep disorder (e.g., sleep apnea, restless legs\u002F periodic limb movements, circadian-based sleep disorder);\n* diagnosed with cognitive impairments;\n* unable to understand Romanian;\n* unable to attend to online-sessions (e.g., no laptop, microphone, camera);","59 Years",{"count":232,"type":22},76,[25],"This is a prospective, randomized-controlled trial that assesses the efficacy of a brief Acceptance and Commitment Therapy (ACT-i), compared to an attentional control group, in adults with chronic insomnia. The interventions will be evaluated for their impact on insomnia severity, cognitive function, depression, anxiety, psychological flexibility, and sleep beliefs - measured before treatment, two weeks after and at a three-month follow-up.",[29,236,237],"Depression - Major Depressive Disorder","Anxiety",[239,240,241,242,243,244],"acceptance and commitment therapy","chronic insomnia","cognitive functions","depression","anxiety","randomized controlled trial","2026-04-03",{"date":247,"type":42},"2026-04-07",{"date":249,"type":42},"2025-05-23",{"date":165,"type":22},{"name":252,"class":49},"Babes-Bolyai University",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":50},"100535394","facial-emotion-recognition-in-insomnia-and-emotional-regulation-100535394","NCT06251258","Facial Emotion Recognition in Insomnia and Emotional Regulation","REFIRE","Pre-inclusion criteria\n\n* Age between 18 and 65\n* Signed consent to participate in the study\n* Person affiliated to or benefiting from a social security scheme\n* For insomnia group: known insomnia (patient treated for insomnia)\n\nInclusion criteria:\n\n* Insomnia group: ISI \\>14 (between 15 and 28 = clinical insomnia)\n* Control group: ISI \\\u003C 8 (between 0 and 7 = no insomnia)\n\nNon-pre-inclusion criteria\n\n* Known psychiatric disorders (Characterized depressive episode, Bipolar disorder, Schizophrenia and other delusional disorders, Specified anxiety disorder (social anxiety, generalized anxiety disorder), Obsessive-compulsive disorder (OCD), Eating disorders, Neurodevelopmental disorders (ASD, ADHD), Active addictive disorders (excluding tobacco), ...)\n* Taking antidepressant, neuroleptic or thymoregulator medication\n* Taking a benzodiazepine with a long half-life (\\>12 hours)\n* Condition requiring hospitalization in the month preceding the study\n* Known sequelae or progressive neurological disease\n* Known significant ophthalmological condition\n* Pregnancy or breast-feeding\n* Person deprived of liberty by judicial or administrative decision\n* Person subject to a legal protection measure\n* Person under psychiatric care without consent\n* For control group: no known insomnia\n\nNon-inclusion criteria :\n\n\\- Psychiatric disorders identified during psychiatric interview",{"count":261,"type":22},128,[25],"Introduction Chronic insomnia is a prevalent disorder in the general population, affecting up to 20% according to French National Institute of Health and Medical Research, leading to a decline in quality of life and an increased risk of developing certain psychiatric disorders, notably major depressive episodes. Chronic insomnia, particularly when accompanied by reduced sleep duration, has been associated with cognitive impairments documented in the literature, such as reduced concentration, working memory, vigilance, and certain executive functions.\n\nWhile some studies suggest subjective cognitive impairment in insomnia, it remains inconclusive when objectively measured. Individuals with chronic insomnia often report a global deterioration in social life, characterized by irritability, attentional difficulties, asthenia, and social isolation. This raises questions about potential impairments in social abilities, particularly in recognizing facial emotions, which may be linked to the subjective complaints of reduced quality of life in individuals with insomnia.\n\nSeveral studies have explored facial emotion recognition in insomnia, with some indicating impairments in emotion recognition or evaluation of emotion intensity. Others demonstrated deficits in recognizing specific emotions (such as anger) or representations (such as fatigue), which were associated with attentional deficits and changes in visual fixation points in eye-tracking studies.\n\nHowever, some authors found no significant association between insomnia complaints and impaired facial emotion recognition. Facial emotion recognition has been studied using eye-tracking in major depressive episodes, attention-deficit\u002Fhyperactivity disorder (ADHD), and autism spectrum disorders. Eye-tracking studies have revealed attentional biases toward negative emotions in depression and deficits in visual attention to the eye region in autism, contributing to impaired facial emotion recognition. To date, no study has compared facial emotion recognition abilities between individuals with insomnia and a control group, considering attentional deficits and emotional dysregulation described in insomnia.\n\nMethods The study aims to compare two groups: one with isolated insomnia (without associated psychiatric disorders) and a control group (without insomnia or psychiatric disorders). Patients with psychiatric or addictive disorders will be excluded based on Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-V) psychiatric interviews. Participants aged over 65 or under 18 will also be excluded to mitigate potential biases related to dementia and cognitive alterations not related to insomnia.\n\nThe insomnia group will consist of individuals seeking care at the Sleep Center of Angers University Hospital for chronic insomnia (lasting more than 3 months). Insomnia will be confirmed using the Insomnia Severity Index (ISI), with a score exceeding 15, while individuals with subclinical insomnia (ISI score between 7 and 15) will be excluded. The control group will have an ISI score below 7 (indicating the absence of insomnia).\n\nThe main objective is to determine whether facial emotion recognition differs between the insomnia and control groups. Secondary objectives include assessing differences between explicit facial emotion recognition tests (controlled conditions) and eye-tracking tests (implicit memory) in both groups to evaluate attentional biases. Additionally, the study aims to explore differences in facial emotion recognition tests based on emotional regulation profiles (adaptive or non-adaptive regulation).\n\nExpected Results The hypothesis is that facial emotion recognition under controlled conditions (explicit memory) will not differ between the insomnia and control groups. However, differences are expected in implicit memory tests (eye-tracking) due to the attentional deficits previously described in insomnia. Additionally, variations in facial emotion recognition are anticipated based on emotional regulation profiles, which may influence facial emotion recognition in insomnia.\n\nThe study's findings could contribute to a better understanding of cognitive complaints related to insomnia, especially in the realm of social interactions, by objectively assessing and specifying potential biases. This research may also inform targeted therapeutic approaches, particularly in cognitive-behavioral therapy, focusing on cognitive remediation and restructuring. Ultimately, the study's outcomes could guide the development of specific rehabilitation programs centered on facial emotion recognition, emotional deficits, and emotional dysregulation in insomnia.",[29],[240,266,267,268],"neuropsychology","facial expression assessment","emotional regulation","2026-03-31",{"date":271,"type":42},"2026-04-06",{"date":273,"type":42},"2025-12-12",{"date":275,"type":22},"2027-09-30",{"name":277,"class":278},"University Hospital, Angers","OTHER_GOV",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100585110","evaluation-of-the-efficacy-of-e2r-hypnotherapy-in-the-management-of-chronic-insomnia-in-primary-care-hyperr-100585110","NCT06898099","Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)","Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care","HypERR","Inclusion Criteria:\n\n* Patient aged 18 or over,\n* Patient suffering from chronic insomnia according to the DSM-5 definition, whether or not treated with psychotropic drugs:\n\n  \\* At least one of the following sleep disorders: difficulty in falling asleep, difficulty in maintaining sleep, waking up too early and inability to go back to sleep, and \\* At least 3 nights a week for at least 3 months, and \\* In an adequate night-time sleep context, and \\* With at least one significant impact on, or impairment of, social, occupational or behavioral functioning, and \\* Insomnia not attributable to the physiological effects of a substance, and \\* Insomnia not explicable by a medical condition or mental disorder.\n* Patient willing to undergo hypnotherapy for 4 sessions of 30 min over 6 weeks,\n* Patient whose treating physician is the investigator,\n* Patient able to give free, informed, written consent,\n* Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n* Patients receiving or having received one or more hypnotherapy sessions (for any reason) in the last 5 years prior to inclusion,\n* Patient participating in another study involving the treatment of insomnia or another pathology having an impact on sleep disorders,\n* Patient unable to complete a self-administered questionnaire,\n* Patients with poor or no understanding of the French language,\n* Patients unable to attend hypnotherapy consultations,\n* Deaf or hard-of-hearing patients without hearing aids,\n* Patient under legal protection (safeguard of justice, curatorship, guardianship) or deprived of liberty,\n* Women declaring themselves pregnant or breastfeeding.",{"count":288,"type":22},136,[25],"In France, the treatment of chronic insomnia relies mainly on hypnotic drugs in routine care, despite the high level of iatrogenicity. Cognitive-behavioral therapy (CBT) is recommended by the HAS as a non-pharmaceutical first-line therapy for chronic insomnia. Despite evidence of their efficacy in chronic insomnia, these therapies remain underdeveloped in France (few practitioners, time-consuming for the patient). Hypnotherapy is another non-drug intervention suitable for routine outpatient care. Among the hypnosis methods practiced in France, E2R (Emotion, Regression, Repair) is a hypnotherapy method used in general practice, particularly for chronic insomnia. To date, no clinical trials have been carried out to demonstrate its effectiveness in this pathology.\n\nThe HypERR study is a multicenter, randomized, open-label study designed to evaluate the efficacy of a hypotherapy method called E2R in the management of chronic insomnia, by comparing it with standard care (without hypnosis).",[29],[240,293,294,295,296],"E2R hypnosis","emotion-focused therapy","primary care","general medicine","2026-03-27",{"date":299,"type":42},"2026-04-02",{"date":301,"type":42},"2025-10-14",{"date":303,"type":22},"2027-04-14",{"name":305,"class":49},"Rennes University Hospital",35,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":50},"100625170","effect-of-yoga-in-chronic-insomnia-100625170","NCT07419152","Effect of Yoga in Chronic Insomnia","Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial","Inclusion Criteria\n\n* Age:18-65 years\n* Either gender\n* Diagnosis of chronic insomnia as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)\n* Ability to understand the study procedures and provide written informed consent Exclusion Criteria\n* A current diagnosis of any other sleep disorder such as RLS, PLMS, circadian rhythm sleep disorder, narcolepsy, parasomnias\n* Suicidal ideation\n* Shift work or trans-meridian travel in last two weeks\n* Pregnant or lactating females\n* Excessive caffeine use\n* History of drug or alcohol abuse\n* Serious chronic conditions or exacerbation of chronic disorder preventing further participation",{"count":315,"type":22},72,[25],"This study will evaluate the effect of the yoga in participants with chronic insomnia. The primary objective is to determine whether adding yoga to standard care improves insomnia severity, as measured by the Insomnia Severity Index (ISI), compared to standard care alone. The study will also assess changes in sleep architecture using polysomnography and examine dysfunctional beliefs and attitudes about sleep.\n\nSecondary objectives include evaluating the effects of yoga on stress biomarkers (salivary cortisol and salivary alpha-amylase) and on somatosensory information processing using quantitative sensory testing. These measures aim to explore possible mechanisms by which yoga may influence insomnia symptoms, including stress modulation and sensory processing changes.\n\nThis assessor-blinded, randomized controlled trial will enroll 72 participants aged 18-65 years diagnosed with chronic insomnia. Participants will be randomly assigned to one of three groups: (1) Yoga + Standard Care (2) Stretching group + Standard Care (3) Standard Care alone. The yoga group and stretching group will receive an 8-week intervention (2 weeks supervised group sessions, followed by 6 weeks home practice with telemonitoring).\n\nAssessments will be performed at baseline, 2 weeks, and 8 weeks. The primary outcome is change in ISI score at 8 weeks. Secondary outcomes include polysomnographic measures, dysfunctional beliefs and attitudes about sleep, depression-anxiety-stress scores, daytime sleepiness, stress biomarker levels, and sensory thresholds",[29],[65,320,321,322,323],"Hyperarousal","Yoga-intervention","Sensory information processing","Microarousals","2026-02-16",{"date":326,"type":42},"2026-02-18",{"date":328,"type":42},"2024-08-14",{"date":330,"type":22},"2029-03",{"name":332,"class":49},"All India Institute of Medical Sciences",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":341,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":343,"conditions":344,"keywords":347,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":50},"100590931","studying-the-neurobiological-mechanisms-of-non-specific-chronic-low-back-pain-and-chronic-insomnia-a-four-group-cross-sectional-study-100590931","NCT06973837","Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study","Unravelling the Neurobiological Mechanisms Underlying the Bidirectional Relationship Between Chronic Sleep Disturbances and Pain Sensitivity in People With Non-specific Chronic Low Back Pain and Chronic Insomnia","SY-NAPS-CS","General inclusion criteria (all groups):\n\n* 18-60 years old.\n* Ability to speak and understand the Dutch Language.\n* Body mass index \\\u003C30.\n* No smoking or nicotine use.\n* Low caffeine use (≤3 cups of coffee\u002Fday, ≤1 energy drink\u002Fday).\n* Low alcohol use (≤9 alcoholic units\u002Fweek).\n* No use of neuro- and\u002For psychopharmacological treatments and\u002For immunosuppressive agents (including NSAIDs) with a suspected influence on neuroinflammation unless terminated within a sufficient time frame before the start of the study, or unless falling under the Pharmacological exceptions criteria (see below).\n* Willing to (try to) adhere to the acute pre-test restrictions, including refraining from analgesics (unless stable use), caffeine, alcohol, and\u002For strenuous physical activity (\\>3 METs) in the 24 hours preceding the main test day.\n\nGeneral exclusion criteria (all groups):\n\n* Shift worker.\n* Use of blood thinners.\n* (History of) Substance dependence\u002Fabuse.\n* Chronic pain conditions (≥3 months) other than chronic low back pain.\n* Severe intrinsic sleep disorders (assessed during a one-night, laboratory-based polysomnography).\n* Restless leg syndrome\n* Central or peripheral neurological disorder\u002Fcondition (e.g., epilepsy, multiple sclerosis, peripheral neuropathy).\n* History of spinal surgery.\n* Major medical (e.g., cardiac disease, cancer) and\u002For psychiatric disorder\u002Fdisease (e.g., major depressive disorder, bipolar disorder).\n* Claustrophobia.\n* Contraindications for magnetic resonance imaging (e.g., metal\u002Fcochlear implants, pacemaker).\n* Pregnancy or being \\\u003C12 months post-natal.\n\nPharmacological exceptions criteria:\n\n\\- Participants with chronic low back pain and\u002For (comorbid) insomnia will be allowed to be on a stable low dose of weak pain and\u002For sleep agents (e.g., Tramadol, Zolpidem) if medically prescribed specifically for their low back pain and\u002For insomnia, and if approved by the national medicine register of Belgium (FAMHP, Federal Agency for Medicine and Health Products). These participants will also be allowed stable and\u002For occasional use of low-to-moderate doses of over-the-counter medications for pain and\u002For sleep that are suspected to have no or minimal impact on neuroinflammation (e.g., paracetamol, melatonin). Habitual use of medications according to the above-stated criteria should be maintained across the entire study period, with the only exception being analgesics taken on an occasional basis. Specifically, because of the extensive battery of pain tests that will be utilized in the study, all analgesics that are only taken occasionally should be refrained from during the 24 hours preceding the main test day (pre-test instructions).\n\nSpecific inclusion criteria for \"pain-free\" groups:\n\n* Currently pain free, defined as having no pain that affects daily living\u002Ffunctioning and\u002For which has led to a consultation with a healthcare practitioner.\n* No episode of low back pain that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within 12 months from the time of inclusion.\n* No history of chronic low back pain.\n\nSpecific inclusion criteria for \"chronic low back pain\" groups:\n\n* Low back pain reported on most days (≥50%), every week, for more than 3 months.\n* Low back pain-related emotional disress OR functional disability rated as ≥3 out of 10.\n\nSpecific inclusion criteria for \"good sleeper\" groups:\n\n* Stable sleep phase within 10 PM and 10 AM (assessed using the Pittsburgh Sleep Quality Index).\n* Average habitual total sleep time between 7 and 9 hours (assessed using the Pittsburgh Sleep Quality Index).\n* A Pittsburgh Sleep Quality Index ≤5.\n* An Insomnia Severity Index ≤7.\n* An Epworth Sleepiness Scale ≤10.\n* Sleep efficiency ≥85% during a one-night, laboratory-based polysomnography screening.\n* No episode of sleep disturbances that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within the preceding 12 months from the time of inclusion.\n* No history of chronic insomnia.\n\nSpecific inclusion criteria for \"chronic insomnia\" groups:\n\n* Chronic insomnia according to the ICSD-3-TR criteria (assessed using an ICSD-3-TR-adapted version of the Pittsburgh Sleep Quality Index).\n* An Insomnia Severity Index ≥15.",{"count":342,"type":22},80,"This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.",[345,29,346],"Chronic Low Back Pain (CLBP)","Neuroinflammation",[348,211,349,69,65,160,350,351,352,353,354,355,356,357,358,359,360,361],"Pain","Chronic low back pain","Magnetic resonance imaging","Functional magnetic resonance imaging","Magnetic resonance spectroscopy","Diffusion weighted imaging","Quantitative sensory testing","Temporal summation","Conditioned pain modulation","Experience sampling method","Ecological momentary assessment","Microbiota","Gut-Brain axis","Short-chain fatty acids","2025-12-06",{"date":364,"type":42},"2025-12-15",{"date":366,"type":42},"2025-10-03",{"date":368,"type":22},"2026-10",{"name":370,"class":49},"Vrije Universiteit Brussel",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":50},"100591657","exploration-of-the-effectiveness-of-vibrational-intervention-in-improving-insomnia-symptoms-100591657","NCT06983275","Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms","Inclusion Criteria:\n\n* Aged 18 to 65 years, regardless of gender;\n* Diagnosed with chronic insomnia disorder according to DSM-5 criteria, with a primary complaint of difficulty falling asleep (sleep onset latency \\> 30 minutes), occurring ≥3 times per week, lasting for more than 3 months but less than 3 years;\n* Able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after instruction.\n\nExclusion Criteria:\n\n* Presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome;\n* Epworth Sleepiness Scale (ESS) score \\> 10;\n* Use of any sleep-related medication within the past month;\n* Patient Health Questionnaire-9 (PHQ-9) score \\> 15 or Generalized Anxiety Disorder-7 (GAD-7) score \\> 10;\n* Currently participating in any form of cognitive behavioral therapy or neuromodulation intervention study;\n* Working night shifts or rotating shifts;\n* Clinically diagnosed neurological disorders such as epilepsy, stroke, dementia, or Parkinson's disease, or psychiatric disorders such as bipolar disorder, obsessive-compulsive disorder, phobias, or panic disorder;\n* Substance abuse (including alcohol or drugs), defined as more than 14 drinks\u002Fweek for males or 12 drinks\u002Fweek for females.",{"count":378,"type":22},120,[25],"Study Purpose The purpose of this clinical trial is to investigate whether low-intensity frontal vibration can improve sleep performance in individuals with chronic insomnia. Additionally, the study aims to explore its potential effects on memory enhancement.\n\nThe primary objectives of the study are to address the following questions:\n\n* Does low-intensity frontal vibration improve sleep performance in patients with chronic insomnia?\n* Does low-intensity frontal vibration enhance memory performance in patients with chronic insomnia?\n\nResearchers will compare the effects of low-intensity frontal vibration with a sham stimulation (in which participants hear only noise associated with the vibration process) to determine whether the active intervention can effectively improve symptoms of chronic insomnia.\n\nParticipant Involvement\n\nParticipants in the study will:\n\n* Record daily sleep diaries via a mobile application for a total of 9 weeks\n* Receive daily intervention during a 4-week intervention phase as scheduled by the study\n* Complete weekly self-reported sleep questionnaires through the app\n* Undergo memory performance assessments at the beginning and end of the study",[29],[240,383,384],"vibrational neuromodulation","vibration","2025-09-15",{"date":387,"type":42},"2025-09-19",{"date":389,"type":42},"2025-09-01",{"date":391,"type":22},"2027-06-01",{"name":393,"class":49},"Jia Xiu",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":17,"minAge":402,"maxAge":92,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":50},"100462429","insomnia-behavioral-intervention-study-100462429","NCT05301543","Insomnia Behavioral Intervention Study","Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia","IBI","Inclusion Criteria:\n\n* Age of 55-85\n* Use of sleeping pill medication for sleep at least 3 nights a week\n* Diagnosed with Chronic Insomnia by a physician\n* Speaks English above a 6th-grade level\n* Has access to a smartphone and\u002For smart tablet and can use it\n* Has regular access to internet\n\nExclusion Criteria:\n\n* Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol\u002Fsubstance abuse, etc.)\n* Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.","55 Years",{"count":121,"type":22},[25],"This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.",[29],"2025-07-15",{"date":409,"type":42},"2025-07-17",{"date":411,"type":42},"2022-01-10",{"date":413,"type":22},"2028-05-20",{"name":84,"class":49},{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":426,"conditions":427,"keywords":458,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":50},"100565622","phase-1-evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-and-chronic-insomnia-100565622","NCT06644573","Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia","PSHW","By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.\n\nINCLUSION CRITERIA:\n\n1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.\n2. Diagnosed or Undiagnosed Chronic Insomnia:\n\n   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.\n3. Diagnosed or Undiagnosed Sleep Deprivation:\n\n   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.\n4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:\n\n   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.\n5. Failure to Respond to Conventional Sleep Treatments:\n\n   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.\n6. Ability to Provide Informed Consent:\n\nReason: Ensures that participants understand the study and agree to participate voluntarily.\n\nEXCLUSION CRITERIA:\n\n1. Severe Obesity (BMI \\> 40):\n\n   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.\n2. Cardiovascular Conditions:\n\n   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.\n3. Neurological Disorders:\n\n   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.\n4. Other Health Conditions Contraindicating Anesthesia:\n\n   Reason: Includes any condition that would make the use of anesthesia unsafe.\n5. Greater than ASA II Status:\n\n   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.\n6. Current Use of Prohibited Medications:\n\n   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.\n7. Pregnancy or Breastfeeding:\n\nReason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.",{"count":423,"type":22},100,[425],"PHASE1","This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.\n\nObjectives: The primary goals of the trial are to determine:\n\n1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.\n2. Whether PSTx increases the duration of REM and\u002For NREM sleep.\n3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).\n\nParticipants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan\u002FPropofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.\n\nParticipant Criteria:\n\nInclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.\n\nExclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.\n\nStudy Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.\n\nParticipants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.\n\nTherapy Methodology:\n\nPROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan\u002FPropofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.\n\nOutcome Measures:\n\nPrimary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.\n\nSecondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.\n\nSignificance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.\n\nStudy Process:\n\nRecruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.\n\nTherapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan\u002FPropofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.\n\nPost-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.\n\nPotential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.\n\nKey Concepts:\n\nHomeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.",[29,186,428,429,430,65,431,432,433,434,435,436,437,438,439,440,441,442,237,443,444,445,446,447,448,449,450,451,452,69,453,131,454,455,348,456,457],"REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Measurement","Insomnia Related to Specified Disorder","Insomnia Due to Other Mental Disorder","Insomnia Comorbid to Psychiatric Disorder","Insomnia Due to Anxiety and Fear","Insomnia Related to Another Mental Condition","Insomnia Disorders","Idiopathic Hypersomnia","Sleep Disorders, Circadian Rhythm","Post Trauma Nightmares","PTSD - Post Traumatic Stress Disorder","Sleep Quality","Anesthesia","Depression","Mental Health","Alzheimer Disease or Associated Disorder","Parkinsons","Circadian Rhythm","Circadian Dysregulation","PTSD","Post-Traumatic","Post-Traumatic Stress Disorder Complex","Military Combat Stress Reaction","Military Activity","Shift Work Sleep Disorder","Menopause Related Conditions","Cancer Pain","Athletes",[459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,65,186,477,437,478,449,444,237,443],"SLEEP","PROSOMNIA Sleep","PROSOMNIA Sleep Therapy","PSTx","PROSOMNIA","Anesthesia Sleep","REM Sleep","REM Sleep Therapy","PROSOMNIA Sleep Health","PROSOMNIA Sleep Wellness","PROSOMNIA Sleep Treatment","Nyree","Nyree Penn","Propofol","Propofol Sleep","Diprivan","Diprivan Sleep","PROSOMNIA Sleep Health and Wellness","IH","Sleep Debt","2025-05-27",{"date":481,"type":42},"2025-05-28",{"date":483,"type":22},"2025-11-01",{"date":80,"type":22},{"name":471,"class":486},"INDUSTRY",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":17,"minAge":494,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":50},"100590564","effect-of-mit-for-ci-with-anxiety-100590564","NCT06969053","Effect of MIT for CI With Anxiety","Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety","Inclusion Criteria:\n\n1. Diagnosed with Insomnia Disorder according to DSM-5 criteria.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5.\n3. Age 8 years or older.\n4. Educational level of at least junior high school.\n5. Voluntarily agree to participate and provide written informed consent.\n6. Presence of anxiety symptoms, defined as Hamilton Anxiety Rating Scale (HAMA) score ≥ 14.\n\nExclusion Criteria:\n\n1. Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.\n2. Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.\n3. Pregnant or breastfeeding women.\n4. Currently undergoing any psychological therapy.","8 Years",{"count":94,"type":22},[25],"This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.",[29,499],"Anxiety Disorders","2025-05-19",{"date":249,"type":42},{"date":503,"type":42},"2024-11-01",{"date":483,"type":22},{"name":506,"class":49},"Xuanwu Hospital, Beijing",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":524,"locationsCount":50},"100590481","effects-of-tai-chi-on-chronic-insomnia-disorder-combined-with-hyperarousalanxiety-100590481","NCT06967974","Effects of Tai Chi on Chronic Insomnia Disorder Combined With Hyperarousal\u002FAnxiety","Evaluation of Tai Chi for Chronic Insomnia Disorder Combined With Hyperarousal\u002FAnxiety","Inclusion Criteria:\n\n1. meet DSM-5 diagnostic criteria for insomnia disorder;\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\>5;\n3. age ≥18 years old with junior high school education or above;\n4. voluntarily participate in this study by signing an informed consent form; and 5) HAMA ≥14 was required for those who had chronic insomnia disorder with anxiety symptoms.\n\nExclusion Criteria:\n\n1. people with comorbid serious physical or severe mental illnesses, suicide risk;\n2. clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers;\n3. pregnant and breastfeeding women; and\n4. people who are currently undergoing any psychological treatment.",{"count":342,"type":22},[25],"This study focuses on individuals with chronic insomnia combined with excessive arousal\u002Fanxiety, with the main objective of investigating the effectiveness of Tai Chi in treating CI with excessive arousal\u002Fanxiety.",[29],[29,519,520,243],"Tai Chi","hyperawareness",{"date":249,"type":42},{"date":503,"type":42},{"date":483,"type":22},{"name":506,"class":49},{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":11,"sex":17,"minAge":494,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":544,"leadSponsor":545,"locationsCount":50},"100590484","effect-of-wbt-for-ci-with-depression-100590484","NCT06968013","Effect of WBT for CI With Depression","Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms","Inclusion Criteria:\n\n1. Diagnosed with Insomnia Disorder according to DSM-5 criteria, with a duration of at least 3 months.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5.\n3. Age 8 years or older.\n4. Educational level of at least junior high school.\n5. Voluntarily agree to participate and provide written informed consent.\n6. Presence of depressive symptoms, defined as Hamilton Depression Scale (HAMD) score ≥ 16.\n\nExclusion Criteria:\n\n1. Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.\n2. Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.\n3. Pregnant or breastfeeding women.\n4. Currently undergoing any psychological therapy.",{"count":533,"type":22},84,[25],"This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.",[29,537],"Depression Disorders",[29,537,539],"Well-Being Therapy","2025-05-05",{"date":542,"type":42},"2025-05-13",{"date":503,"type":42},{"date":483,"type":22},{"name":506,"class":49},{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":558,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":50},"100566667","effects-of-cognitive-correction-and-stimulus-control-in-chronic-insomnia-patients-100566667","NCT06658158","Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients","Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients With Sleep Cognitive Distortions and Maladaptive Sleep Patterns","Inclusion Criteria:\n\n1. Meets the diagnostic criteria for insomnia disorder according to DSM-5;\n2. PSQI total score \\> 5;\n3. Age ≥ 18 years, with at least a junior high school education;\n4. Sleep cognitive distortions assessed using the DBAS-16;\n5. \"Maladaptive Sleep Behavior Questionnaire - 8 items\" used to assess \"maladaptive sleep behaviors\";\n6. Willing to participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Presence of severe physical illness or serious mental disorders, or at risk for suicide;\n2. Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;\n3. Pregnant or lactating women;\n4. Currently undergoing any form of psychological therapy.",{"count":554,"type":22},88,[25],"This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.",[29],[240,559,560,561],"cognitive correction","stimulus control","sleep hygiene education",{"date":563,"type":42},"2025-05-09",{"date":565,"type":42},"2024-12-01",{"date":567,"type":22},"2025-12-01",{"name":506,"class":49},{"id":570,"slug":571,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":580,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":585,"locationsCount":50},"100566669","effects-of-sleep-restriction-and-stimulus-control-in-chronic-insomnia-patients-100566669","NCT06658184","Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients","Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for insomnia disorder as per DSM-5.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5.\n3. Age ≥ 18 years, at least a junior high school education level.\n4. Assessment of sleep-wake behavior by sleep diary.\n5. Assessment of \"maladaptive sleep behavior\" by self-designed 8-item questionnaire.\n6. Voluntary participation in the study and signing an informed consent form.\n\nExclusion Criteria:\n\n1. Presence of severe physical or severe mental illness, and suicide risk.\n2. Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work.\n3. Pregnant or lactating women.\n4. Currently undergoing any form of psychological therapy.",{"count":554,"type":22},[25],"The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\\' sleep habits and maladaptive sleep behaviors.",[29],[240,581,560,561],"sleep restriction",{"date":563,"type":42},{"date":565,"type":42},{"date":567,"type":22},{"name":506,"class":49},{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":601,"locationsCount":50},"100566668","effects-of-relaxation-training-and-stimulus-control-in-chronic-insomnia-patients-100566668","NCT06658171","Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients","Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for insomnia disorder according to DSM-5.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5.\n3. Age ≥ 18 years, with at least a middle school education level.\n4. Anxiety symptoms meeting HAMA ≥ 14.\n5. \"Self-developed 8-item questionnaire on maladaptive sleep behaviors\" used to assess \"maladaptive sleep behaviors.\"\n6. Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.\n2. Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.\n3. Pregnant or lactating women.\n4. Currently undergoing any psychological therapy.",{"count":554,"type":22},[25],"The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.",[29],[240,581,560,561],{"date":563,"type":42},{"date":503,"type":42},{"date":483,"type":22},{"name":506,"class":49},{"id":603,"slug":604,"hasResults":11,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":202,"sex":17,"minAge":608,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":50},"100486740","lemborexant-vs-zopiclone-vs-clonidine-for-insomnia-treatment-in-chronic-pain-patients-100486740","NCT05618002","Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients","Inclusion Criteria:\n\n* adult chronic pain patients\n* good treatment compliance\n* severe chronic insomnia\n* failure of non-pharmacologic sleep therapy\n* regular zopiclone therapy for 3 months or more\n* regular sleep diary\n* regular pain diary\n* informed consent for diary review\n* consent for clinical record quality assurance review\n\nExclusion Criteria:\n\n* obstructive sleep apnoea\n* body mass index (BMI) ≥40\n* organ insufficiency\n* cognitive disorder\n* inability to provide consent\n* major neuropsychiatric disorder\n* unreliable diary\n* cannabis use\n* regular alcohol intake\n* stimulant use\n* substance abuse\n* poor treatment compliance\n* high dose opioid\n* gabapentinoid use\n* sedative use\n* mild insomina\n* irregular zopiclone intake\n* regular zopiclone therapy for less than 3 months\n* previous adverse\u002Fallergic reactions to clonidine or zopiclone","20 Years","99 Years",{"count":611,"type":22},150,"Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.",[29,208],[615,616],"Sedative","Hypnotic","2025-01-23",{"date":619,"type":42},"2025-01-27",{"date":621,"type":42},"2022-11-08",{"date":623,"type":22},"2025-12-11",{"name":625,"class":49},"Salem Anaesthesia Pain Clinic",{"id":627,"slug":628,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":634,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":645,"locationsCount":4},"100572027","a-randomized-single-blind-study-evaluating-the-efficacy-and-cost-effectiveness-of-brief-behavioral-therapy-for-chronic-insomnia-patients-under-medication-treatment-at-nguyen-trai-hospital-ho-chi-minh-city-100572027","NCT06727916","A Randomized, Single-Blind Study Evaluating the Efficacy and Cost-Effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City","Evaluation of Efficacy and Cost-effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City","Inclusion Criteria:\n\nThe study includes patients who fully meet the following criteria:\n\nPatients with an outpatient prescription diagnosed with \"sleep disorder\" (ICD-10: G47), insomnia disorder \\[difficulty initiating and maintaining sleep\\] (ICD-10: G47.0), nonorganic insomnia (ICD-10: F51.0), or agrypnia \\[sleep disorder\\] (ICD-10: U55.621). Diagnoses are based on DSM-5 criteria.\n\nPatients aged 18 years or older. Agreement to participate in the study.\n\nExclusion Criteria:\n\nCognitive impairment (inability to understand counseling content). Presence of a triggering factor during the study period (hospitalization, acute exacerbation of comorbid conditions, or a psychological trauma) as these conditions may induce insomnia.\n\nConditions incompatible with sleep restriction therapy:\n\nEpilepsy. Untreated obstructive sleep apnea (diagnosed or high-risk based on STOP-BANG screening).\n\nUntreated bipolar disorder. Suicidal intent. Parasomnias related to NREM sleep (sleepwalking, night terrors). Diagnosed with other sleep disorders.",{"count":423,"type":22},[25],"Insomnia disorder is considered quite common and is recognized as a risk factor for psychiatric disorders. In industrialized countries, chronic insomnia disorder is estimated to affect about 5-10% of the population, with some studies indicating that this rate can reach up to 33% among adults. Research in the Netherlands has shown that insomnia symptoms increase the risk of developing, relapsing, and prolonging mood disorders in men and are associated with recurrent anxiety disorders in women. Without treatment, insomnia disorders are challenging to improve and can impact patients' economic stability and health. Treating insomnia can support recovery and prevent mental disorders, particularly mood disorders.\n\nOne of the commonly referenced non-pharmacological treatments for insomnia worldwide is Cognitive Behavioral Therapy for Insomnia (CBT-I). This therapy has been recognized by the American College of Physicians as a first-line and highly effective treatment for insomnia. However, it still faces several barriers to widespread application in clinical practice, such as resource constraints and the time commitment required from patients. As a result, some studies abroad have shown that physicians may be reluctant to recommend CBT-I alone, even though it is considered the preferred treatment. To address these challenges, numerous international studies have expanded the range of providers (such as pharmacists and nurses) or adopted shortened versions, such as Brief Behavioral Treatment for Insomnia (BBT-I), in hospitals or community pharmacies. BBT-I has been proven effective among older adults with a 2+2 design (two in-person sessions and two follow-up calls) and among younger adults using an electronic format. This is a brief, evidence-based therapy designed to encourage the application of CBT-I techniques in primary healthcare settings, demonstrating effectiveness when performed by healthcare providers with basic training. A significant advantage of combining CBT-I and BBT-I in treating insomnia is the reduction in medication use. When effectively implemented, it can shorten treatment duration, reduce hospitalization rates, decrease adverse effects from drug interactions, and improve patients' quality of life, ultimately reducing the financial burden on healthcare facilities and improving the quality of medical services.\n\nIn Vietnam, CBT-I and BBT-I therapies are not yet widely applied or popularized. Based on the current situation and the desire to apply these therapies in treating chronic insomnia patients to improve quality of life and reduce medication costs, in 2023, Nguyen Trai Hospital collaborated with Thong Nhat Hospital and the Saigon Center for Pharmaceutical Science and Technology to conduct a city-level scientific and technological research program on the application of BBT-I in supporting the treatment of chronic insomnia in the elderly. The research developed a \"Sleep Support Guide\" as a resource for healthcare workers to counsel patients and provide essential information related to insomnia. Results from the study also showed that BBT-I could help improve sleep-related parameters, life quality, and sleep quality among elderly patients. However, the study had some limitations, such as being conducted only on elderly subjects, with a follow-up period of one month post-intervention for sleep parameters and three months for medication usage metrics, without a cost-effectiveness comparison with medication-only treatments. Therefore, further in-depth research with a wider range of subjects and a comparison with standard hospital treatments is necessary for broader application of this method in practice.\n\nObjective 1: To investigate the characteristics of chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.\n\nObjective 2: To assess the effectiveness of BBT-I in improving sleep quality and quality of life after one and three months compared to non-application in chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.\n\nObjective 3: To evaluate the cost-effectiveness of BBT-I in improving sleep quality and quality of life when applied to chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.",[67,29,637,213],"BBT-I",[639,240,637,213],"Chronic insomnia disorder","2024-12-06",{"date":218,"type":42},{"date":643,"type":22},"2024-12-15",{"date":275,"type":22},{"name":646,"class":49},"Nguyen Trai Hospital",{"id":648,"slug":649,"hasResults":11,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":11,"sex":654,"minAge":18,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":23,"phases":657,"briefSummary":658,"conditions":659,"keywords":660,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":50},"100501756","digital-cognitive-behavioral-therapy-for-insomnia-for-chronic-insomnia-in-breast-cancer-survivors-100501756","NCT05813392","Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors","Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Breast cancer diagnosed within 5 years\n3. Stable disease at the end of acute treatment (surgery, radiotherapy, chemotherapy) while meeting: ≥ 1 month after surgery, ≥ 3 months after the end of last chemotherapy, and ≥ 3 months after the end of last radiotherapy if radiotherapy is required.\n4. Satisfy the diagnostic criteria for chronic insomnia disorder according to the (International Classification of Sleep Disorders-the Third Edition, ICSD-3)\\[ and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): problem with falling asleep or maintaining sleep for ≥3 months (≥3 times per week) with impaired daytime functioning, despite the availability of sleep opportunities.\n5. ISI score ≥12.\n6. Other sleep or psychiatric disorders, if present, must be stable and require no medication.\n7. Be proficient in the use of a cell phone application, and be comfortable reading, filling out the electronic questionnaire, communicating, and fully understanding the content.\n8. Sign the informed consent form. -\n\nExclusion Criteria:\n\n1. New breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen\n2. Expected survival \\\u003C12 months due to all causes\n3. Presence of any of the following conditions: Concurrent active cancer or malignancy that is being treated other than breast cancer, shift work, alcohol abuse, substance abuse, significant suicidal ideation, bipolar disorder, aggressive behavior, mania, schizophrenia.\n4. Presence of a diagnosed significant physical illness that interferes with sleep, such as cranial disease or trauma, cancer pain, unstable angina, uncontrolled cardiac insufficiency and severe respiratory distress due to various causes, etc.\n5. Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I).\n6. Not signed informed consent.","FEMALE",{"count":656,"type":22},264,[25],"To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) \"resleep\". Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.",[29],[65,661,662],"Cognitive Behaviour Therapy for insomnia","breast cancer","2024-10-21",{"date":665,"type":42},"2024-10-22",{"date":667,"type":42},"2023-08-29",{"date":669,"type":22},"2026-08-29",{"name":671,"class":49},"Peking University First Hospital",{"id":673,"slug":674,"hasResults":11,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":23,"phases":681,"briefSummary":683,"conditions":684,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":4},"100555459","phase-3-a-study-of-ramelteon-in-chinese-patients-with-chronic-insomnia-100555459","NCT06512363","A Study of Ramelteon in Chinese Patients With Chronic Insomnia","A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years old.\n* Chronic insomnia disorder diagnosed according to International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) criteria.\n* Self-reported history of all the following on at least 3 nights per week within 4 weeks prior to screening: subjective sleep latency (sSL) greater than or equal to 30 minutes, and subjective total sleep time (sTST) less than or equal to 6.5 hours per night.\n* Meeting all the following sleep parameters on the 2 PSG nights during the run-in period: mean latency to persistent sleep (LPS) ≥ 20 min (with neither of the two nights \\\u003C 15 min), and mean wake after sleep onset (WASO) ≥ 30 min (with neither of the two nights \\\u003C 20 min).\n* Usual bedtime between 20:30 and 01:00, and regular time in bed between 6.5 and 9 h.\n* Insomnia Severity Index score≥15 at screening and on Day 1 of the treatment period.\n* Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.\n\nExclusion Criteria:\n\n* Use of ramelteon within 30 days prior to screening.\n* Previous non-responders to melatonin receptor agonist therapy.\n* Known hypersensitivity to ramelteon or related compounds, including melatonin.\n* Sleep schedule changes required by employment (e.g. shift worker), or has flown across greater than three time zones (mainland China is considered as 1 time zone) within 30 days prior to screening and during the study period; or special professionals who need to operate machinery during the study period, such as professional drivers, high-altitude operators, etc.\n* Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to screening and during the study period.\n* Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.\n* Previous history of other sleep disorders secondary to other diseases including moderate to severe obstructive sleep apne, circadian rhythm sleep disturbances, paroxysmal sleeping sickness, and restless legs syndrome.\n* Apnea-hypopnea index (AHI) and periodic limb movement index (PLMI) \\> 15 times\u002Fhour detected by PSG monitoring during the run-in period.\n* Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.\n* Hamilton Anxiety Scale (HAMA) score ≥ 14 and Hamilton Depression Scale (HAMD) score ≥ 18 at screening.\n* Have serious diseases of cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, immune system, etc., which are not suitable for the study judged by the investigators.\n* AST or ALT \\> 3 × ULN, and TBIL \\> 2 × ULN.\n* Patients with HIV or syphilis infection.\n* Use of any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, strong CYP1A2 inhibitors, strong CYP2C9 inhibitors, strong CYP3A4 inhibitors, strong CYP inducers, or any other therapies for insomnia disorder within 1 week prior to the run-in period or within 5 half-lives of the investigational product, whichever is longer.\n* Requirement of taking any prohibited medication during study period.\n* History of drug abuse within 1 year prior to screening, or positive urine drug screening.\n* History of alcohol abuse within 1 year prior to screening, or unwilling to follow alcohol restriction during the study period.\n* Regular daily consumption of excessive tea and coffee drinks, or unwilling to follow tea\u002Fcoffee restriction during the study period.\n* History of smoking addiction or unwilling to follow tobacco restriction during the study period.\n* Participated in any other investigational study and taken any investigational drug within 1 month or 5 half-lives prior to screening, whichever is longer.\n* Pregnant or lactating women, or planning to have children or both men of reproductive potential and women of childbearing potential disagree to use ≥1 effective contraception throughout the study and within 3 months after the end of the study.\n* MEQ-19 score ≤ 49.\n* Other conditions that are not considered appropriate by the investigator.",{"count":680,"type":22},280,[682],"PHASE3","The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.\n\nEfficacy will be evaluated on objective and subjective sleep parameters.",[29],"2024-07-16",{"date":687,"type":42},"2024-07-22",{"date":689,"type":22},"2024-08",{"date":691,"type":22},"2026-12",{"name":693,"class":486},"Nanjing Chia-tai Tianqing Pharmaceutical"]