[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-insomnia-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-insomnia-disorder":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,52,79,104,131,157],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100634674","phase-4-a-smart-approach-to-evaluating-the-benefits-of-common-prescription-and-otc-medications-for-insomnia-100634674",false,"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","ALL","18 Years","80 Years",{"count":20,"type":21},1200,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28,29,30],"Insomnia","Insomnia Disorder","Chronic Insomnia","Chronic Insomnia Disorder",[32,27,33,34,35,36,37,38],"Sleep","Zolpidem","Diphenhydramine","Doxepin","Melatonin","Trazodone","Placebo","RECRUITING","2026-06-04",{"date":42,"type":43},"2026-06-05","ACTUAL",{"date":45,"type":43},"2026-05-01",{"date":47,"type":21},"2032-01-01",{"name":49,"class":50},"University of Pennsylvania","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":51},"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":61,"type":21},70,[63],"NA","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.",[27,29,30,66],"Sleep Disturbance",[68,30,27],"Sleep Efficiency","NOT_YET_RECRUITING","2026-05-12",{"date":72,"type":43},"2026-05-19",{"date":74,"type":21},"2026-05-20",{"date":76,"type":21},"2028-06-30",{"name":78,"class":50},"San Francisco Neurology and Sleep Center",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":51},"100630377","comparing-acoustic-resonance-therapy-art-vs-cognitive-behavioral-therapy-for-insomnia-cbt-i-100630377","NCT07486882","Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)","A Feasibility Pilot Comparing Acoustic Resonance Therapy (ART) to Cognitive Behavioral Therapy for Insomnia (CBT-I) for Treating Patients With Moderate to Severe Chronic Insomnia Disorder","Inclusion Criteria:\n\n* Adult subjects, 22 years of age and older at screening\n* Moderate-to-severe insomnia disorder, as defined by the International Classification of Sleep Disorders (ICSD-3)\\* and the Insomnia Severity Index (ISI) and have been diagnosed for more than three months.\n* Not pregnant by subject self-report at time of consent.\n* Have the ability to provide informed consent.\n* Have the ability to complete all aspects of this trial.\n* Have access to an iOS mobile device (iPhone X or above).\n* Have no contraindicating comorbid health condition that would interfere with the proper use of the SONU Headband system, as determined by the clinical investigators.\n* Participants who are taking sleep-aiding pills must agree to no changes to medication and dosage during the study.\n\n  * According to the third edition of the International Classification of Sleep Disorders (ICSD-3), insomnia is characterized by difficulty in either initiating sleep, maintaining sleep continuity, or poor sleep quality\n\nExclusion Criteria:\n\n* Patients who are unable to commit to avoiding the consumption of alcohol during the study.\n* Patients who are unable to commit to avoid consumption of caffeine after 12 pm (noon).\n* Patients who have a clinically significant or unstable medical or surgical condition.\n* Participants using pacemakers or cardiac monitors.\n* Participants with severe physical illness or immediately post-surgery\n* Participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases such as a seizure, stroke, or Parkinson's disease.\n* Participants with other serious sleep disorders, such as severe obstructive sleep apnea.\n* Participants who are unable to attend regular follow-up evaluations.\n* Any unstable medical or mental health condition as determined by the physician investigator.","22 Years",{"count":88,"type":21},60,[63],"The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) arm versus those randomized to the SONU Headband Acoustic Resonance Therapy (ART) arm at end of treatment (6 weeks).",[30],[93,94,95],"insomnia","cognitive behavioral therapy","acoustic resonance therapy","2026-03-17",{"date":98,"type":43},"2026-03-23",{"date":96,"type":43},{"date":101,"type":21},"2027-07-31",{"name":103,"class":50},"Mayo Clinic",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":51},"100571991","translation-and-validation-of-the-french-version-of-the-sleep-regularity-questionnaire-a-new-tool-to-address-the-the-challenge-of-sleep-health-100571991","NCT06727448","Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health","PRIMO","Inclusion Criteria:\n\n* Patient ≥ 18 years of age\n* Patient with indication for 14-day actimetry for chronic insomnia or circadian rhythm disorder\n* Patients with an indication for 14-day actimetry to assess sleep-wake rhythms, for example prior to a 36-hour polysomnographic recording to diagnose central hypersomnia (narcolepsy or idiopathic hypersomnia).\n* Patient affiliated to or benefiting from a social security scheme\n* Patient with French as mother tongue, able to read and write French.\n* Patient able to understand and complete questionnaires independently\n* Patient informed and not opposed to participating in the study\n\nExclusion Criteria:\n\n* Current psychiatric disorder (mood disorders, anxiety, psychosis, sleep-interfering use disorder) assessed during interview with investigator\n* Current neurological disorder affecting sleep (neurodegenerative disease, stroke, epilepsy) assessed during interview with investigator\n* Unstable cardiovascular or respiratory diseases\n* Pregnant or breast-feeding women\n* Adults under guardianship or curatorship\n* Opposition to participation expressed by healthy patient\u002Fvolunteer",{"count":112,"type":21},50,"OBSERVATIONAL","Sleep is an essential function for physical and mental health. The mismatch between biological rhythms and the social rhythms of individuals is increasingly common in modern societies. This sleep irregularity can have numerous consequences on mental health, cardiometabolic health, the immune system, functioning, and quality of life. To address the public health issue of sleep irregularity, it is important to be able to obtain a valid and reliable measure. The Sleep Regularity Questionnaire (SRQ) by Dzierzewski et al. addresses this issue, but has never been translated into French. The aim of the study is to translate and validate the French version of the Sleep Regularity Questionnaire.",[30,116],"Circadian Rhythm Disorders",[118,119,120,121],"circadian rhythm disorder","Sleep Regularity Questionnaire","SRQ","chronic insomnia disorder","2025-12-09",{"date":124,"type":43},"2025-12-10",{"date":126,"type":43},"2024-12-23",{"date":128,"type":21},"2026-06-23",{"name":130,"class":50},"University Hospital, Bordeaux",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"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":139,"type":21},100,[63],"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.",[30,29,143,144],"BBT-I","CBT-I",[146,147,143,144],"Chronic insomnia disorder","chronic insomnia","2024-12-06",{"date":150,"type":43},"2024-12-11",{"date":152,"type":21},"2024-12-15",{"date":154,"type":21},"2027-09-30",{"name":156,"class":50},"Nguyen Trai Hospital",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":51},"100562728","fmt-for-insomnia-disorder-fmt-sleep-100562728","NCT06606938","FMT for Insomnia Disorder (FMT-SLEEP)","Faecal Microbiota Transplantation for Insomnia Disorder: a Randomized, Double-blind, Placebo-controlled Trial","Inclusion Criteria:\n\n* 1\\. Individuals aged 18 and above\n* 2\\. Subjects who were diagnosed with chronic insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and with moderate or above insomnia disorder defined as ISI \\> 14\n\nExclusion Criteria:\n\n* 1\\. Having an additional sleep disorder, such as restless legs syndrome, or circadian rhythm sleep disorder, that can significantly disrupt the sleep cycle as ascertained by Diagnostic Interview for Sleep Patterns and Disorders (DISP)\n* 2\\. Requiring immediate psychiatric care (e.g., imminently suicidal subjects) or have attempted suicide in the past 6 months\n* 3\\. Change of treatment or therapy for insomnia within 4 weeks\n* 4\\. Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection\n* 5\\. Confirmed active malignancy\n* 6\\. Had abdominal surgery\n* 7\\. Contraindications to GI endoscopy\n* 8\\. On shift work\n* 9\\. Taking antibiotics, probiotic or prebiotic preparations within 4 weeks\n* 10\\. Known pregnancy\n* 11\\. Mental retardation or inability to provide informed consent\n* 12\\. Are participating in other interventional studies",{"count":165,"type":21},74,[63],"Insomnia disorder is characterized by difficulty initiating or maintaining sleep, or early morning awakening accompanied by symptoms such as irritability or fatigue during wakefulness. It is one of the most prevalent health concerns in the population and in clinical practice, with more than one-third of adults experience transient insomnia at some point in their lives. In about 40% of cases, insomnia can develop into a more chronic condition. The COVID-19 pandemic has further aggravated sleep problems, with a reported global prevalence of sleep disturbances reaching 40-49%. The implications of insomnia disorder are substantial, encompassing social, economic, psychological, and physical aspects.\n\nBehavioural, cognitive, and pharmacological interventions can all be effective for insomnia. Pharmacological treatment is commonly used but may have drawbacks such as adverse events and inconclusive safety data for certain medications. Many licensed drugs can be effective in the acute treatment of insomnia but are associated with poor tolerability, or information about long-term effects is not available. Alternatively, cognitive behavioural therapy for insomnia (CBT-I), has been recommended as the first-line treatment for chronic insomnia in adults of any age according to the American and European guidelines. But issue of accessibility, compliance\u002Fadherence, and moderate response limit the practicality and applicability of CBT-I.\n\nRecent evidence suggests that the gut microbiota plays a role in regulating sleep behaviour, both directly and indirectly. This has led to the exploration of gut microbiota modulation as a potential therapy for insomnia. Faecal microbiota transplantation (FMT), which is the infusion of faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for various diseases. Several real-world studies have demonstrated improvements in symptoms of insomnia disorder following FMT. One previous study also indicated the potential of FMT in alleviating post-COVID insomnia. In this randomised, double-blind, placebo-controlled trial, the investigators aim to assess the efficacy of FMT in improving insomnia disorder. Two groups will be recruited in 1:1 ratio. The intervention group will receive FMT while the control group will receive normal saline as placebo. Both groups will have the same assessments.",[30],[170],"Faecal Microbiota Transplantation","2024-09-19",{"date":173,"type":43},"2024-09-23",{"date":175,"type":21},"2024-11-01",{"date":177,"type":21},"2027-04-30",{"name":179,"class":50},"Chinese University of Hong Kong"]