[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insomnia-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insomnia-disorder":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,46,78,108,139,162,193,219,240,267,293,318,343,369,393,425,447],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100635557","auricular-acupuncture-therapy-administered-by-village-doctors-improves-sleep-quality-in-elderly-patients-with-comorbid-diabetes-mellitus-and-hypertension-100635557",false,"NCT07554235","Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension","Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension","Inclusion Criteria:\n\n1. Age ≥65 years;\n2. Patients with comorbid diabetes mellitus and hypertension:\n3. Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) total score ≥8;\n4. Willing to participate in this study and sign the informed consent form;\n5. Has resided in this village for at least six months.\n\nExclusion Criteria:\n\n1. Stroke;\n2. Severe mental illness or cognitive impairment;\n3. Severe organ failure (e.g., end-stage renal disease);\n4. Ear infection, eczema, breakage, or deformity;\n5. Currently receiving regular other acupuncture treatments;\n6. Use of any hypnotic medications within the past month\n7. Bleeding disorders or use of anticoagulants (increased bleeding risk);\n8. History of fainting during acupuncture;\n9. Life expectancy less than six months.","ALL","65 Years",{"count":19,"type":20},320,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study aims to apply traditional auricular press-needle acupuncture to treat sleep disturbances in elderly patients (aged ≥65 years) with comorbid diabetes mellitus and hypertension in rural areas of China. Given the complex bidirectional relationship between diabetes mellitus with hypertension and sleep disturbances, this cluster randomized trial is designed to test whether a village doctor-led intervention model supported by telemedicine can improve sleep disturbances in patients with comorbid diabetes mellitus and hypertension, compared to sham auricular press-needle acupuncture. Participants will be recruited by local village doctors according to the inclusion and exclusion criteria. The protocol is based on Traditional Chinese Medicine theory for core point selection: Heart, Liver, Kidney, Shenmen, and Forehead area, along with optimized medication regimens supported by remote cardiovascular specialists. The investigators will evaluate the overall improvement in sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at the end of the 6-week treatment period, and assess sleep disturbances, anxiety, depression, daytime sleepiness, and fatigue at 12 weeks.",[26,27,28],"Insomnia Disorder","Diabetes","Hypertension",[30,31,28,27,32],"Village Doctors","Acupuncture needles","insomnia","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2026-04-22",{"date":41,"type":20},"2027-02-20",{"name":43,"class":44},"Jiangsu Taizhou People's Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100645001","phase-3-a-study-to-evaluate-the-safety-of-hs-10506-in-chinese-patients-with-insomnia-disorder-100645001","NCT07677384","A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder","A Multicenter, Open-label, Phase 3 Study to Evaluate the Short-term and Long-term Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder","Inclusion Criteria:\n\n1. Participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);\n2. Participants are required to voluntarily sign the informed consent form;\n3. Body mass index (BMI): BMI (weight\u002Fheight2 \\[kg\u002Fm2\\]) must be in the range of 18 to 35 kg\u002Fm2 (inclusive);\n4. For Participants completed Study 301: Participants have completed the Study 301, can potentially benefit from extended treatment with HS-10506 and have no major safety risks according to the investigator's clinical judgment;\n5. For new Participants: Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;\n6. For new Participants: Participants must have Insomnia Severity Index (ISI) scores≥15 at screening;\n7. For new Participants: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST\\\u003C6.5 hours for at least three nights every week within one month prior to screening; and sSOL≥30 minutes, sWASO≥30 minutes, and sTST\\\u003C6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before the first dose in the open-label treatment period;\n\nExclusion Criteria:\n\n1. Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;\n2. Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;\n3. Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single\u002Fmulti-target drugs within the past 2 weeks or 5 half-lives of the medication;\n4. Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;\n5. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;\n6. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;\n7. Has a history of smoking≥10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;\n8. Has a history of caffeine consumption≥600 mg per day or can't obey the rules of caffeine restriction;\n9. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;\n10. Has taken more than 3 naps per week for\\>1 hour each time within the past 2 weeks prior to screening;\n11. Has any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.\n12. For Participants completed Study 301: Has been diagnosed with a sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder during Study 301, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n13. For Participants completed Study 301: Has been diagnosed with neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases during Study 301; or other systemic diseases that are inappropriate for the study;\n14. For Participants completed Study 301: Previously participated in any clinical trial other than HS-10506-301 within 3 months prior to screening;\n15. For new Participants: Has history of\u002Fcurrent sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n16. For new Participants: Has history of\u002Fcurrent neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;\n17. For new Participants: Previously use of HS-10506;\n18. For new Participants: Previously participated in any clinical trial within 3 months prior to screening.","18 Years","64 Years",{"count":56,"type":20},600,[58],"PHASE3","The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.",[26],[62,63,64,65,66],"Clinical trial","insomnia disorder","open-label","long-term","phase 3","NOT_YET_RECRUITING","2026-06-24",{"date":70,"type":37},"2026-06-30",{"date":72,"type":20},"2026-06-12",{"date":74,"type":20},"2029-06-30",{"name":76,"class":77},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":45},"100510283","phase-4-daridorexant-to-treat-insomnia-in-patients-with-mild-cognitive-impairment-and-mild-to-moderate-alzheimer-disease-100510283","NCT05924425","Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease","DARIDOR-ALZ","Inclusion criteria :\n\n* Age \\[60-85\\] years old\n* Outpatients\n* Pre-screening:\n\n  * Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and\n  * Total sleep time causes clinically significant distress or impairment in daytime functioning, and\n  * Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening\n* Baseline PSG (at randomization) assessed TST \\\u003C 6 hours and WASO \\> 1 hour\n* Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive CSF Aβ42 and\u002For positive plasma biomarker, and neuronal injury (hippocampal and\u002For temporal atrophy by MRI))\n* MMSE from 12 to 26\n* Clinical Dementia Rating CDR from 0.5 to 2\n* Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol).\n* For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed\n\nNon inclusion criteria :\n\n* Patients significantly dependent on caregivers\n* Institutionalized patients\n* Analphabetism or subjects unable to read or\u002Fand write\n* Patients unable to perform the neuropsychological tests\n* Patients unable to complete the study instruments (sleep diary)\n* Planned longer stay outside the region that prevents compliance with the visit schedule\n* Patients who cannot be followed up for at least 2 months\n* History of narcolepsy and\u002For cataplexy\n* History of drug or alcohol abuse or addiction\n* History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry\n* Moderate and severe liver failure\n* PSG baseline evidence of significant\u002Fsevere sleep-related breathing disorder (defined as \\>30 apnea\u002Fhypopnea episodes per hour)\n* Treatments interfering with sleep-wake patterns\n* Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives)\n* Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)\n* Forbidden and restricted concomitant medications:\n\n  * Concomitant CNS-depressant medicinal products\n  * CYP3A4 inhibitors\n  * CYP3A4 inducers\n* Participation in another clinical trial or administration of an investigational product\n* Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship).\n* Subjects not covered by public health insurance\n* Failure to obtain written informed consent after a reflection period","60 Years","85 Years",{"count":88,"type":20},62,[90],"PHASE4","DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.",[93,26,94],"Alzheimer Disease","Sleep",[96,97,98,99,94,100],"Orexin","Daridorexant","Cognition","Alzheimer","Insomnia",{"date":34,"type":37},{"date":103,"type":37},"2024-03-13",{"date":105,"type":20},"2028-03-13",{"name":107,"class":44},"University Hospital, Montpellier",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":45},"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":117,"type":20},1200,[90],"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).",[100,26,121,122],"Chronic Insomnia","Chronic Insomnia Disorder",[94,100,124,125,126,127,128,129],"Zolpidem","Diphenhydramine","Doxepin","Melatonin","Trazodone","Placebo","2026-06-04",{"date":132,"type":37},"2026-06-05",{"date":134,"type":37},"2026-05-01",{"date":136,"type":20},"2032-01-01",{"name":138,"class":44},"University of Pennsylvania",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100589396","phase-3-evaluating-the-effects-of-tasimelteon-vs-placebo-in-treating-pediatric-insomnia-100589396","NCT06953869","Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia","A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia","Inclusion Criteria:\n\n* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).\n* Confirmed clinical diagnosis of insomnia disorder\n* Males and Females between 2 and 17 years, inclusive.\n* The sleep disturbance must not be a result of another medication.\n\nExclusion Criteria:\n\n* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.\n* Indication of impaired liver function.\n* Pregnant or lactating females.\n* A positive test for drugs of abuse.","2 Years","17 Years",{"count":149,"type":20},420,[58],"This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.",[26],"2026-06-03",{"date":132,"type":37},{"date":156,"type":37},"2025-04-21",{"date":158,"type":20},"2028-01",{"name":160,"class":77},"Vanda Pharmaceuticals",35,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":45},"100638337","virtual-reality-relaxation-for-insomnia-100638337","NCT07630532","Virtual Reality Relaxation for Insomnia","Virtual Reality Relaxation Intervention for Individuals With Insomnia","Inclusion Criteria:\n\n* Aged between 25 and 50 years\n* Experiencing difficulty initiating sleep, maintaining sleep, or early-morning awakenings at least three times per week for a minimum of three months\n* Residing within a 25-km radius of Université Laval\n\nExclusion Criteria:\n\n* Diagnosis of serious medical conditions (e.g., cancer, neurological disorders, chronic pain) or major psychiatric disorders\n* Conditions that could be exacerbated by virtual reality devices (e.g., epilepsy, eye disorders, dizziness, balance disorders)\n* Adverse effects related to virtual reality use (e.g., dizziness, nausea)\n* Currently using prescription or over-the-counter sleep aids\n* Engaged in night shifts or rotating shift work","25 Years","50 Years",{"count":172,"type":20},30,[23],"The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effects of a virtual reality (VR) relaxation intervention among adults aged 25 to 50 with insomnia disorder.\n\nThe main questions this study aims to address are:\n\n* Is a VR relaxation intervention feasible to implement and acceptable for individuals with insomnia?\n* Does the intervention reduce pre-sleep cognitive and somatic arousal?\n* Does the intervention improve sleep quality and sleep depth?\n* Can the intervention enhance overall sleep health and reduce symptoms of insomnia, anxiety, and depression?\n* Are these potential benefits maintained at a 3-month follow-up?\n\nParticipants will be randomly assigned to either the intervention group or a waitlist control group. Researchers will compare outcomes between groups to evaluate the impact of the intervention.\n\nParticipants will:\n\n* Complete online questionnaires at three time points (baseline, post-intervention, and 3-month follow-up) assessing sleep health, pre-sleep arousal, and symptoms of insomnia, anxiety, and depression\n* Take part in an in-person diagnostic interview at Université Laval to assess sleep and mental health status\n* Complete a daily online sleep diary for 8 weeks (2 weeks baseline, 4 weeks intervention, and 2 weeks post-intervention)\n* Engage in a 15-minute VR-guided meditation session each evening at home for 4 weeks\n* Wear a portable sleep monitor at home for 8 nights (4 nights baseline and 4 nights post-intervention)\n* Complete an acceptability questionnaire following the intervention",[26],[177,178,179,180,181,182,183,184],"Insomnia disorder","Hyperarousal","Virtual reality","Polysomnography","Sleep quality","Guided meditation","Slow breathing","Sleep health","2026-06-01",{"date":132,"type":37},{"date":188,"type":37},"2025-09-01",{"date":190,"type":20},"2027-09",{"name":192,"class":44},"Laval University",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":85,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100634246","inulin-spirulina-co-intervention-for-insomnia-disorder-100634246","NCT07537192","Inulin-Spirulina Co-intervention for Insomnia Disorder","Investigation of the Therapeutic Efficacy and Mechanistic Pathways of Inulin-Spirulina Co-intervention in Patients With Insomnia Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 60 years;\n2. Meet the ICSD-3 diagnostic criteria for chronic insomnia disorder;\n3. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5;\n4. Willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\n1. Use of prebiotics, probiotics, high-fiber supplements, or microbiota-related products within the past 8 weeks;\n2. Diagnosis of psychiatric disorders other than insomnia based on DSM-5 criteria, assessed using the Mini-International Neuropsychiatric Interview (MINI);\n3. Regular use of sedative or hypnotic medications within the past 4 weeks, or frequent intermittent use (e.g., benzodiazepines, non-benzodiazepine receptor agonists, melatonin receptor agonists, sedating antihistamines);\n4. Severe hepatic or renal dysfunction, hematologic disorders, or respiratory diseases;\n5. Severe gastrointestinal diseases or malnutrition;\n6. Pregnancy or breastfeeding;\n7. Apnea-hypopnea index \\> 10, or periodic limb movement index \\> 15\u002Fhour on polysomnography;\n8. Known allergy or intolerance to inulin, spirulina, or maltodextrin;\n9. Participation in another clinical trial within the past 3 months.",{"count":201,"type":20},180,[23],"The goal of this clinical trial is to learn if inulin and spirulina, used alone or in combination, can improve insomnia disorder in adults aged 18 to 60 years with chronic insomnia disorder. It will also learn about the safety of these interventions. The main questions it aims to answer are:\n\nDoes inulin plus spirulina improve sleep quality, as measured by the reduction rate in Pittsburgh Sleep Quality Index (PSQI) score? Does the intervention improve sleep-related, mood, anxiety, and cognitive outcomes after 12 weeks? Researchers will compare an inulin group, a spirulina group, a combined inulin plus spirulina group, and a placebo group to see if the combined intervention provides greater benefit than either single intervention or placebo.\n\nParticipants will:\n\nbe randomly assigned to 1 of 4 groups: inulin, spirulina, inulin plus spirulina, or placebo; take the assigned study product once daily for 12 weeks; complete sleep, mood, anxiety, and cognitive assessments at baseline and week 12; undergo polysomnography and provide blood and stool samples at baseline and week 12; and be monitored for adverse events throughout the study.",[26,205],"Sleep Initiation and Maintenance Disorders",[207,208,209,210,100],"Inulin","Spirulina","Gut Microbiota","Gut-Brain Axis","2026-05-15",{"date":213,"type":37},"2026-05-19",{"date":134,"type":20},{"date":216,"type":20},"2027-04-30",{"name":218,"class":44},"First Affiliated Hospital of Zhejiang University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100640374","phase-3-a-study-of-hs-10506-in-chinese-patients-with-insomnia-disorder-100640374","NCT07587385","A Study of HS-10506 in Chinese Patients With Insomnia Disorder","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder","Inclusion Criteria:\n\n1. participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);\n2. participants are required to voluntarily sign the informed consent form;\n3. Body mass index (BMI): BMI (weight\u002Fheight2 \\[kg\u002Fm2\\]) must be in the range of 18 to 35 kg\u002Fm2 (inclusive);\n4. Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;\n5. Participants must have Insomnia Severity Index (ISI) scores ≥ 15 at screening and run-in period;\n6. Subjective sleep assessment: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST \\\u003C 6.5 hours for at least three nights every week within one month prior to screening; and sSOL ≥ 30 minutes, sWASO≥30 minutes, and sTST \\\u003C 6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before V2 visit and V3 visit respectively;\n7. PSG: Participants must demonstrate a 2-night mean LPS ≥ 30 minutes with neither night \\\u003C 20 minutes, a 2-night mean WASO ≥ 30 minutes with neither nigh \\\u003C 20 minutes, and a 2-night mean TST \\\u003C 7 hours.\n\nExclusion Criteria:\n\n1. Has history of\u002Fcurrent sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n2. Has a Apnea-Hypopnea Index (AHI) ≥ 10 times\u002Fhour or periodic leg movement with arousal index (PLMAI) ≥ 10 times\u002Fhour monitored by PSG at V2 visit;\n3. Has history of\u002Fcurrent neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;\n4. Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;\n5. Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single\u002Fmulti-target drugs within the past 2 weeks or 5 half-lives of the medication;\n6. Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;\n7. Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;\n8. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;\n9. Has taken more than 3 naps per week for \\> 1 hour each time within the past 2 weeks prior to screening;\n10. Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;\n11. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;\n12. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;\n13. Has a history of smoking ≥ 10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;\n14. Has a history of caffeine consumption ≥ 600 mg per day or can't obey the rules of caffeine restriction;\n15. Previously participated in any clinical trial of HS-10506;\n16. Has any circumstances or conditions, which, in the opinion of the investigator, may affect the participant's full participation in the study or compliance with the protocol.",{"count":227,"type":20},732,[58],"The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.",[26],[62,63,66],"2026-05-08",{"date":234,"type":37},"2026-05-14",{"date":236,"type":20},"2026-05-29",{"date":238,"type":20},"2028-08-12",{"name":76,"class":77},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":45},"100595765","optimizing-an-integrated-mind-and-body-treatment-for-insomnia-the-sleeps-study-2-100595765","NCT07036705","Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2","SLEEPS2","Inclusion Criteria:\n\n* 18 years or older\n* English-speaking\n* Willing to use birth control if assigned female sex at birth\n* Willing to receive study text messages during participation\n* Location to plug sauna blanket into regular wall outlet\n* Ability to lie in sauna blanket for 15 minutes\n* Ability to fit in the sauna blanket\n* Daily access to the internet via computer, smartphone, or tablet\n* Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI) at two screening timepoints\n* Primary insomnia disorder (characterized by difficulty initiating sleep) as indexed by a positive diagnosis on the Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD)\n\nExclusion Criteria:\n\n* Night shift or swing shift worker\n* Current or planned routine body heating practices (e.g., saunas, hot tubs, long baths) within 4 hours before bed that are 10 minutes or more in duration (≥2x per week)\n* Pregnant or plans to become pregnant during the participation period\n* Traveling internationally between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\\~1 week)\n* Other diagnosed sleep disorders or suspected sleep disorders\n* Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket\n* Medication use that might increase the risk of passive body heating using an infrared sauna blanket\n* Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction\n* Medical condition that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction\n* Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic disorder\n* Current (past 3 months) major depressive disorder\n* Current (past 12 months) suicidality, alcohol use disorder, other substance use disorder (except mild cannabis use disorder), panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, attention-deficit\u002Fhyperactivity disorder, post-traumatic stress disorder, and eating disorders\n* If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks\n* Currently receiving cognitive behavioral therapy for insomnia (CBT-I)",{"count":248,"type":20},40,[23],"This two-arm randomized trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) to all participants and passive body heating (PBH) sessions using a sauna blanket to half of participants over a 9-week treatment period. Participants are adults aged 18 years or older with insomnia disorder.",[26],[253,254,255,26,256,257,258],"Passive Body Heating","Cognitive Behavioral Therapy for Insomnia","CBT-I","Digital Intervention","Mood Disorders","PBH",{"date":260,"type":37},"2026-04-24",{"date":262,"type":37},"2025-09-29",{"date":264,"type":20},"2027-07",{"name":266,"class":44},"University of California, San Francisco",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":274,"sex":16,"minAge":53,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":45},"100499201","brief-behavioral-treatment-for-insomnia-in-veterans-with-posttraumatic-stress-disorder-100499201","NCT05780177","Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder","BBTI & PTSD","Inclusion Criteria:\n\n* Individuals between the ages of 18-75 years who served in the military\n* Veterans who meet DSM-5 Criteria for Insomnia Disorder.\n* Veterans who meet DSM-5 Criteria for current PTSD\n* If currently taking insomnia, PTSD or other psychotropic medications, must be stable on these medications for at least one month and not make any changes to medications during the active treatment phase of the study.\n* If currently receiving any type of psychotherapy, must have received this treatment for at least one month and do not plan to discontinue treatment during the BBTI trial. Individuals planning to start a new type of psychotherapy will be required to wait one month prior to study enrollment. Individuals currently engaged or planning to engage in evidence-based treatments that are recognized by the VA as directly targeting insomnia or PTSD (i.e., Cognitive Behavioral Therapy for Insomnia, Cognitive Processing Therapy, or Prolonged Exposure Therapy) must complete treatment and wait one month prior to screening for the trial.\n* The investigators will not exclude individuals with TBI, given that prior studies have found that individuals with mild to severe TBI can benefit from behavioral interventions for insomnia.\n* The investigators will not exclude individuals with chronic pain, given that prior studies have found that these individuals can benefit from behavioral interventions for insomnia.\n* The investigators will not exclude individuals with treated sleep apnea or untreated sleep apnea or individuals that are high-risk for sleep apnea. Prior research has found that these individuals can benefit from behavioral interventions for insomnia. Recent research has also established that individuals with untreated mild, moderate or severe sleep apnea or those high-risk for sleep apnea are more likely to receive assessment and treatment for this condition after completing behavioral treatment for insomnia.\n\nExclusion Criteria:\n\n* Veterans with a lifetime history of psychotic disorder or manic episodes.\n* Veterans with moderate to severe alcohol or substance use disorder.\n* Veterans with recent homicidal behaviors. Veterans with suicidal ideation will not be excluded. However, Veterans with recent suicidal behaviors or hospitalization or those who report prominent suicidal ideation with intent or a plan will be excluded.\n* Veterans who are pregnant\n* Veterans who work night or rotating shifts\n* Veterans with unstable housing\n* Veterans with untreated medical conditions that are known to affect sleep (e.g., restless legs syndrome)\n* Veterans with uncontrolled seizure disorder. Sleep restriction is contraindicated for people with uncontrolled seizures due to the possibility of triggering a seizure.\n* Veterans who are unable to participate in video treatment sessions or complete online surveys.",true,"75 Years",{"count":277,"type":20},200,[23],"This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.",[281,26],"Posttraumatic Stress Disorder",[283,100],"PTSD","2026-04-15",{"date":286,"type":37},"2026-04-21",{"date":288,"type":37},"2023-05-01",{"date":216,"type":20},{"name":291,"class":292},"VA Office of Research and Development","FED",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":45},"100541893","mental-imagery-and-targeted-memory-reactivation-in-insomnia-100541893","NCT06335784","Mental Imagery and Targeted Memory Reactivation in Insomnia","Inclusion Criteria:\n\n* Age between 18 and 45 years\n* Insomnia disorder according to the International Classification of Diseases 3 (ICSD-3)\n* ISI \\> 10\n* PSQI \\> 5\n* No other current treatment for Insomnia\n\nExclusion Criteria:\n\n* patients with another psychiatric disorder requiring acute treatment according to DSM-5\n* patients with medical (e.g. neurological disorders) or other disorders explaining the predominant complaint of insomnia (e.g., sleep apneas with ODI\\>15\u002Fh, restless legs syndrome, periodic limb movements with PLM\\>15, chronic pain)\n* patients with significant substance use\u002Fwithdrawal\n* patients with heavy smoking\n* known pregnancy\n* patients suffering from anosmia, olfactory related issues and respiratory pathology","45 Years",{"count":301,"type":20},120,[23],"In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).\n\nPatients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session\u002Fweek) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.\n\nClinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).\n\nAt the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment (\"rocking bed\") in which they will be cradled for one night.\n\nThe investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition.",[26],[100,306,307,308],"Odors","Imagery","TMR","2026-03-02",{"date":311,"type":37},"2026-03-03",{"date":313,"type":37},"2024-04-22",{"date":315,"type":20},"2027-08-31",{"name":317,"class":44},"University Hospital, Geneva",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":325,"maxAge":275,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":4},"100616506","phase-4-compound-ciwujia-granules-in-the-treatment-of-insomnia-100616506","NCT07306494","Compound Ciwujia Granules in the Treatment of Insomnia","Compound Ciwujia Granules in the Treatment of Insomnia: a Multi-center, Double-blind, Double-dummy, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition \\[DSM5\\]);\n2. self-reported history of disturbed sleep (i.e, all the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, and self-reported total sleep time of ≤6·5 h) on at least three nights per week for at least 3 months before screening;(3) diagnosis of \"deficiency of the heart and the spleen pattern\" or \"Qi deficiency of the heart and gallbladder pattern\" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023;\n\n(4) baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.\n\nExclusion Criteria:\n\n1. self-reported allergy symptoms to any of the ingredients;\n2. serious physical sickness;\n3. a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy;\n4. baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;\n5. pregnant women;\n6. history of drugs or alcohol abuse\u002Fdependence;\n7. presence of other sleep disorders including sleep apnoea, restless legs syndrome;\n8. night, morning or rotating shift work;\n9. participation in concurrent clinical trials.","40 Years",{"count":117,"type":20},[90],"The goal of this multicenter, double-blind, double-dummy, randomized controlled trial was to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia. A total of 1200 participants with chronic insomnia were randomly assigned to receive one of the three treatment for 4 consecutive weeks: Compound Ciwujia Granules + placebo of estazolam, estazolam + placebo of estazolam + placebo of Compound Ciwujia Granules, or Compound Ciwujia Granules + estazolam + placebo of estazolam. Outcomes were assessed at 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The main questions it aims to answer are:\n\n1. Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification\u002Finsomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.\n2. Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?",[26],[331,332,333,32],"Compound Ciwujia Granules","multicenter","randomized controlled trial","2025-12-14",{"date":336,"type":37},"2025-12-29",{"date":338,"type":20},"2026-01",{"date":340,"type":20},"2028-06",{"name":342,"class":44},"Hui Zhu",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":274,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":45},"100567539","the-sleep-clinic-outcome-and-practice-study-100567539","NCT06669507","The Sleep Clinic Outcome and Practice Study","The Sleep Clinic Outcome and Practice Study: The SUP-study","SUP","Inclusion Criteria:\n\n* Referred to the Sleep Clinic at St. Olavs Hospital for an assessment of a sleep-wake disruption.\n* Age \\>= 18 years.\n* Willing and able to provide written informed consent.\n* Meeting the diagnostic criteria for at least one of the following disorders: F51.0 Insomnia disorder or G47.2 Sleep-wake rhythm disorders, considered being either: Delayed sleep-wake phase disorder, Advanced sleep-wake phase disorder, Non-24-hour sleep-wake disorder or Irregular sleep-wake disorder\n* Desire non-pharmacological sleep treatment\n\nExclusion Criteria:\n\n* Individuals working night shifts or that otherwise have external conditions that result in inadequate sleep opportunity, such as caring for an infant or does not have permanent housing etc.\n* Individuals being blind\n* Individuals being psychotic\n* Individuals having epilepsy\n* Individuals having an ongoing substance abuse",{"count":352,"type":20},3400,[23],"The goal of this clinical trial is to explore the outcome and practice treatment for sleep-wake disturbances in a Sleep Clinic. The main questions it aims to answer are:\n\n* What is the practice (timing and duration of treatment components) of sleep-wake disturbance treatment?\n* What is the treatment effect of sleep-wake disturbance treatment.\n\nParticipants will receive treatment as usual by consultations with a trained psychiatrist or psychologist and will be asked to fill out self-reporting questionnaires and sleep diaries.",[26,356],"Circadian Rhythm Sleep Disorder",[26,356,358,255,359],"Sleep treatment","Chronotherapy","2025-06-18",{"date":362,"type":37},"2025-06-24",{"date":364,"type":37},"2025-01-01",{"date":366,"type":20},"2030-12-31",{"name":368,"class":44},"St. Olavs Hospital",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":21,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":45},"100575966","efficacy-of-cbt-i-and-lemborexant-medication-for-different-subtypes-of-chronic-insomnia-100575966","NCT06779149","Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia","Inclusion Criteria:\n\n* 18 years of age or older at the time of enrolment\n* Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder (Duke Sleep Interview), with total Insomnia Severity Index (ISI) score \\> 10, and score ≥ 2 on either the interference or distress item\n* Minimal symptoms of anxiety and\u002For depression with Patient Health Questionnaire (PHQ-9) \\> 4 and\u002For Generalized Anxiety Disorder (GAD-7) \\> 4\n* Ability to read and understand French or English\n* Ability to use a smartphone, tablet, or computer, and access to home internet connection\n\nExclusion Criteria:\n\n* Presence of a lifetime diagnosis of any psychotic or bipolar disorder\n* Untreated psychiatric disorder (e.g., major depression) or risk for suicide\n* Substance\u002Falcohol use disorder within the past year\n* Any life-threatening or progressive medical illness (e.g., cancer, chronic obstructive pulmonary disease) or neurological degenerative disease (e.g., dementia)\n* Current use of sleep-promoting medications (prescribed or over-the-counter) or cannabis-derived products for sleep more than two nights per week\n* Current use of tricyclic antidepressants, monoamine oxidase inhibitors, or atypical antidepressants\n* Reported diagnosis of sleep disorder other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, rapid eye movement behavior disorder, delayed phase sleep disorder, narcolepsy)\n* Total score \\> 5 on the Stop-Bang Questionnaire and\u002For clinical symptoms suggestive of sleep apnea (excessive daytime sleepiness), or Epworth score \\> 10, restless legs syndrome or other signs of other sleep disorders\n* Atypical sleep schedules (i.e., habitual bedtimes later than 2:00 AM and rising times later than 10:00 AM on more than two days\u002Fnights per week as documented from a sleep diary)\n* Working night shifts more than five nights per month in the last six months\n* Consuming 2 or more alcoholic beverages per day regularly (3 days or more per week)\n* Any contra-indications to using the study medication, including lung disease\u002Fbreathing problems (e.g., chronic obstructive pulmonary disease), use of strong or moderate CYP3A inducers (strong - rifampin, carbamazepine, and St. John's Wort) (moderate - bosentan, efavirenz, etravirine, and modafinil), pregnant and breastfeeding women\n* Not using any method of birth control",{"count":376,"type":20},90,[23],"The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety\u002Fdepressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +\u002F- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.",[26],[100,381,382,383,384],"Cognitive behavioral therapy for insomnia","Lemborexant","Insomnia phenotypes","Objective short sleep duration","2025-04-05",{"date":387,"type":37},"2025-04-09",{"date":389,"type":37},"2025-04-01",{"date":391,"type":20},"2027-02",{"name":192,"class":44},{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":115,"enrollmentInfo":401,"targetDuration":4,"studyType":21,"phases":403,"briefSummary":404,"conditions":405,"keywords":411,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100575042","comparative-efficacy-of-brt-and-cbt-i-for-insomnia-100575042","NCT06767137","Comparative Efficacy of BRT and CBT-I for Insomnia","Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial","SLEEPwindow","Inclusion Criteria:\n\n* Must meet DSM-5 criteria for insomnia disorder.\n* Adults aged 18 to 80 years\n* Capable of giving written informed consent.\n* Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.\n\nExclusion Criteria:\n\n* Unstable, progressive, or degenerative medical condition\n* Acute pain or poorly managed chronic pain\n* Suicidality\n* Uncontrolled psychiatric condition requiring treatment outside of study\n* Alcohol or drug abuse or dependency\n* Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder\n* Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)\n* Evidence of intellectual disability\n* Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)\n* Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)\n* Current other psychotherapy for insomnia\n* Known pregnancy or breastfeeding\n* Inability to comply with study procedure\n* Insufficient fluency in German or French to complete the study",{"count":402,"type":20},160,[23],"This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.",[406,26,100,407,408,409,410],"Insomnia Disorders","Insomnia Chronic","Insomnia, Primary","Insomnia, Nonorganic","Insomnia Type; Sleep Disorder",[32,412,413,414],"cognitive behavioral therapy","bedtime restriction","sleep restriction","2025-02-13",{"date":417,"type":37},"2025-02-17",{"date":419,"type":20},"2025-03-10",{"date":421,"type":20},"2027-11-01",{"name":423,"class":44},"Christoph Nissen",2,{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":432,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":446},"100569496","digital-cbt-i-for-chronic-insomnia-100569496","NCT06695000","Digital CBT-I for Chronic Insomnia","A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia","Inclusion Criteria:\n\n* Meets diagnostic criteria for insomnia disorder according to the International Classification of Diseases, 10th Revision (ICD-10), including: F51: Nonorganic sleep disorders; G47: Sleep disorders\n* Has experienced insomnia symptoms for 3 months or longer.\n* Scores 8 or higher on the Insomnia Severity Index (ISI).\n* Oral and written fluency in Korean\n* Owns a smartphone and is independently able to use apps on a smartphone.\n* Voluntarily agrees to participate in this clinical study and provides signed informed consent.\n\nExclusion Criteria:\n\n* Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.\n* Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:\n\n  * Obstructive sleep apnea (G47.30)\n  * Sleep behavior disorders\n  * Restless leg syndrome (G28.8)\n  * Narcolepsy (G47.4)\n* Has an active, ongoing physical illness that impedes daily functioning, such as:\n\n  * Congestive heart failure\n  * Chronic obstructive pulmonary disease (COPD)\n  * Acute pain\n  * Neurological disorders (e.g., cerebrovascular disease)\n  * Neurodegenerative disorders (e.g., dementia, multiple sclerosis)\n  * Unstable medical conditions or life expectancy of less than 6 months\n* Adjustments in schedule or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within the past 3 months, or use of PRN (as needed) prescribed sleep medications.\n* Engaged in shift work.\n* Pregnant individuals or those planning to become pregnant during the study period.\n* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities","19 Years",{"count":301,"type":20},[23],"This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.",[407,26],"2024-11-15",{"date":439,"type":37},"2024-11-19",{"date":441,"type":20},"2025-01",{"date":443,"type":20},"2026-03",{"name":445,"class":77},"WELT corp",5,{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":274,"sex":16,"minAge":455,"maxAge":147,"enrollmentInfo":456,"targetDuration":4,"studyType":21,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":424},"100552390","sleep-and-eating-behaviours-in-adolescents-100552390","NCT06472466","Sleep and Eating Behaviours in Adolescents","\"Healthier and Earlier Through Digital Technology: Towards a Transdiagnostic Staging Model of Eating and Sleep Disorders in Adolescence\"","SANA","Inclusion Criteria:\n\n* age ≥ 14; ≤ 17 years old\n* knowledge of Italian language\n* own a device with internet connection","14 Years",{"count":457,"type":20},854,[23],"Insomnia and eating disorders are highly prevalent among adolescents, often co-occur, and are associated with somatic and mental comorbidities and functional impairment. The first aim of this project is to longitudinally monitor psychological functioning and sleep- and eating-related behaviours in a large sample of students aged 14-17 yrs. (N = 854), to identify the variables that predict transition from a prodromal phase to a clinical stage, and signpost individuals at risk or with clinical symptoms to self-help materials and clinical support. The second aim is to test whether increased emotional reactivity to disease-related stimuli (stimuli related to sleep or eating) in a virtual reality environment can discriminate between individuals at risk or with clinical symptoms and healthy peers. The third goal is to conduct a pilot randomized controlled trial to test a virtual reality self-help exposure-based intervention to remediate eating or sleep difficulties in individuals at risk or exhibiting clinical symptoms of eating disorders or insomnia.",[461,26],"Eating Disorders",[463,464,465,466,100,467,468],"Mental health","Adolescence","Eating","Sleep Health","Virtual Reality","Longitudinal","2024-06-17",{"date":471,"type":37},"2024-06-25",{"date":473,"type":20},"2024-09-01",{"date":475,"type":20},"2025-09-30",{"name":477,"class":44},"University of Padova"]