[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-initiation-and-maintenance-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-initiation-and-maintenance-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,75,103,136,170,196,221,246,270,292],{"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":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100590813","phase-1-mindfulness-meditation-for-insomnia-100590813",false,"NCT06972303","Mindfulness Meditation for Insomnia","A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder","Inclusion Criteria:\n\n* Age 18 years and older;\n* Chronic insomnia (≥ 3 nights\u002Fweek, for ≥ 3 months), defined by DSM-V or ICSD-3;\n* Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency \\>20 min;\n* Insomnia Severity Index score ≥ 15;\n* Speak and understand English;\n* Have a smart device (phone or tablet) for mobile app installation\n\nExclusion Criteria:\n\n* Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.);\n* Shift worker or routine night shifts;\n* Women with pregnancy or breastfeeding;\n* Regular (defined as twice a week or more) practice of mind-body interventions;\n* Patients with pace-maker or routinely using cardiovascular medications that have effects on heart rates (i.e., beta-blockers);\n* Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders;\n* Currently under medications with sleep changing effects (e.g., anxiolytics\u002Fbenzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.);\n* Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.",[27,28,29,30,31],"Sleep Initiation and Maintenance Disorders","Insomnia","Insomnia Chronic","Mindfulness","Telemedicine","RECRUITING","2026-06-21",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2026-03-31",{"date":40,"type":20},"2028-12-29",{"name":42,"class":43},"Brigham and Women's Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100558279","a-transdiagnostic-sleep-health-intervention-for-veterans-with-ptsd-100558279","NCT06549049","A Transdiagnostic Sleep Health Intervention for Veterans With PTSD","A Randomized, Controlled Trial of a Modified Sleep and Circadian Intervention for Veterans With PTSD: Advancing Psychosocial Rehabilitation Through Sleep Health","Inclusion Criteria:\n\n* U.S. Military Veteran aged 18 and above engaged in VA primary and\u002For mental health care\n* CAPS 5 PTSD diagnosis; or CAPS 5 score \\>=25 in the absence of full criteria\n* SCID Insomnia Disorder diagnosis, supported by ISI score \\>=10\n* CAPS-IV nightmare score \\>=4\n* Sleep-related functional impairment based on a WHODAS score \\>=32\n* Willingness to engage in 8-12 sessions of treatment to address their sleep disturbance\n\nExclusion Criteria:\n\n* Current cognitive problems, active psychosis or mania, or other mental\u002Fcognitive conditions such as moderate to severe neurodegenerative disease that would render the participant unable to connect to videoconferencing platform, engage in remote psychotherapy, or communicate using the required VA secure email platform\n* No access to reliable internet service connected to a computer, iPad or similar device (telephone not adequate)\n* Inability or unwillingness to use a VA-approved videoconferencing platform and VA secure email;\n* Current engagement in a sleep-focused psychotherapy, or plan to start a sleep-focused psychotherapy in the next 3 months. Sleep-focused psychotherapies include, but are not limited to, CBT-I, BBT-I, and IRT",{"count":53,"type":20},182,[55],"NA","Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.",[58,27],"Stress Disorders, Post-Traumatic",[28,60,61,62,63],"Posttraumatic stress disorder","Veterans","Nightmares","Psychotherapy","NOT_YET_RECRUITING","2026-06-04",{"date":67,"type":36},"2026-06-08",{"date":69,"type":20},"2026-09-01",{"date":71,"type":20},"2029-01-31",{"name":73,"class":74},"VA Office of Research and Development","FED",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"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.","60 Years",{"count":84,"type":20},180,[55],"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.",[88,27],"Insomnia Disorder",[90,91,92,93,28],"Inulin","Spirulina","Gut Microbiota","Gut-Brain Axis","2026-05-15",{"date":96,"type":36},"2026-05-19",{"date":98,"type":20},"2026-05-01",{"date":100,"type":20},"2027-04-30",{"name":102,"class":43},"First Affiliated Hospital of Zhejiang University",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":135},"100637422","clinical-investigation-to-observe-the-long-term-safety-and-efficacy-of-the-digital-medical-device-bell-001-in-patients-diagnosed-with-insomnia-100637422","NCT07582809","Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia","A Multicenter, Single-arm, Prospective Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia","Inclusion Criteria:\n\n* Diagnosed with ICD-11 nonorganic insomnia (F51.0) or sleep initiation and maintenance disorder (insomnia, G47.0)\n* Insomnia Severity Index (ISI) score ≥ 15\n* Adults aged 19 to 75 years\n* Capable of using a smartphone or tablet and has access to a stable internet connection\n* Willing to provide written informed consent voluntarily and able to comply with all study procedures\n* Agrees not to initiate any other insomnia treatment other than cognitive behavioral therapy for insomnia during the trial\n* Has completed sleep diary entries for at least 3 out of 7 days from the day after the screening visit through the day of the baseline visit (Visit 2)\n* At the baseline visit (Visit 2), sleep diary data from the preceding 7 days confirms at least 3 nights with a sleep onset latency of 30 minutes or more, or wake after sleep onset of 60 minutes or more\n\nExclusion Criteria:\n\n* Individuals with severe psychiatric disorders, including major depressive disorder\n* Individuals diagnosed with or suspected of having insomnia comorbid with narcolepsy (G47.4), obstructive sleep apnea (G47.30), restless legs syndrome (G25.81), periodic limb movement disorder (G47.61), or REM sleep behavior disorder (G47.52) per ICD-10-CM codes\n* Individuals with active physical illness or unstable medical conditions that interfere with activities of daily living, including congestive heart failure, chronic obstructive pulmonary disease (COPD), acute pain, cerebrovascular disease (e.g., stroke), or neurodegenerative disorders (e.g., dementia, multiple sclerosis)\n* Individuals whose insomnia symptoms are considered to be caused or exacerbated by the physiological effects of medications (prescription drugs or substances of abuse) or alcohol\n* Individuals deemed by the investigator to be unable to participate in the study due to respiratory conditions such as asthma\n* Individuals with moderate or greater hearing loss in both ears\n* Individuals suspected of sleep medication dependence at the investigator's discretion\n* Individuals with a history of change in the type or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within 4 weeks prior to the baseline visit (Visit 2)\n* Individuals currently reporting persistent tinnitus symptoms\n* Individuals diagnosed with shift work sleep-wake disorder, or those who experience periodic insomnia or sleep-wake rhythm disturbance due to a work environment requiring repeated circadian readjustment, such as day\u002Fnight shift rotation or frequent international travel\n* Individuals who took PRN (as-needed) sleep medications during the screening period (including the day before Visit 1)\n* Individuals who used other investigational drugs or investigational digital medical devices within 3 months prior to Visit 1 I-ndividuals with prior experience using BELL-001\n* Individuals deemed inappropriate for participation in the clinical trial by the investigator for any other reason","19 Years","75 Years",{"count":113,"type":20},40,[55],"This study is a multicenter, single-arm, prospective clinical trial designed to observe the long-term safety and effectiveness of the digital medical device BELL-001 in patients diagnosed with insomnia. Insomnia is a common sleep disorder that can significantly affect daytime functioning, mood, and overall quality of life. Many patients continue to experience difficulties despite lifestyle modifications or pharmacological treatment, and there is a growing need for safer, non-pharmacological therapeutic options.\n\nBELL-001 is a smartphone-based therapeutic device that delivers personalized auditory stimulation during the pre-sleep period. The device is designed to promote relaxation and support the transition into sleep by analyzing individual breathing patterns and providing synchronized sound feedback. This study evaluates the long-term safety and effectiveness of BELL-001 over approximately 3 months (12 weeks) of use.\n\nForty adults diagnosed with insomnia will participate as the BELL-001 group. Participants will use the device for 12 weeks. During the study period, insomnia severity, depression, anxiety, and work productivity will be assessed. The outcome measures include changes in the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Work Productivity and Activity Impairment Questionnaire (WPAI) at 4, 8, and 12 weeks compared to baseline; changes in Total Sleep Time (TST), Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), and sleep stage ratios measured via Nearable Device at 4, 8, and 12 weeks; and changes in subjective Sleep Latency (sSL), subjective Sleep Quality (sSQ), subjective Wake After Sleep Onset (sWASO), subjective number of awakenings after sleep onset, subjective Sleep Efficiency (sSE), and subjective Total Sleep Time (sTST) assessed through sleep diaries at 4, 8, and 12 weeks compared to baseline. Safety will be evaluated over the 12-week period. Additional outcome measures will include assessment of compliance and satisfaction.\n\nThis clinical trial is conducted at multiple hospitals in Korea and adheres to ethical guidelines, including review and approval by Institutional Review Boards (IRBs). Participation is voluntary, and all individuals will provide informed consent prior to the initiation of any study procedures. The results of this study are expected to provide key evidence for the clinical application of a digital, non-pharmacological intervention for adults with insomnia.",[28,27],[118,119,120,121,122,123,124],"BELL-001","Digital Therapeutics","Insomnia Treatment","Auditory stimulation","Biofeedback","Autonomic Regulation","Breathing-Synchronized Therapy","2026-05-06",{"date":127,"type":36},"2026-05-13",{"date":129,"type":20},"2026-06",{"date":131,"type":20},"2026-12",{"name":133,"class":134},"BELL Therapeutics Inc.","INDUSTRY",3,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":143,"minAge":17,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":149,"conditions":150,"keywords":155,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":44},"100635247","phase-2-tiaoshen-anti-cancer-protocol-and-cbt-for-insomnia-and-survival-in-ovarian-cancer-100635247","NCT07550205","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years (inclusive).\n2. Performance status (PS) score of 0-2.\n3. Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy.\n4. Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy.\n5. Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance \\[nocturnal awakening ≥2 times\\], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month).\n6. Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school).\n7. Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.\n\nExclusion Criteria:\n\n1. Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia.\n2. History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications.\n3. Pregnant or lactating women.\n4. Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems.\n5. Language barriers that would prevent completion of assessments or therapy.\n6. Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants.\n7. Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases.\n8. History of chronic alcohol dependence.\n9. Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.).\n10. Participation in any other clinical trial within 3 months prior to enrollment.\n11. Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.","FEMALE","80 Years",{"count":146,"type":20},360,[24,148],"PHASE3","Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.\n\nIntervention \\& Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.\n\nParticipants will be randomly assigned to one of two groups for the initial 18-week phase:\n\nExperimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).\n\nControl Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.",[151,27,152,153,154],"Ovarian Neoplasms Malignant","Medicine, Chinese Traditional","Chinese Herbal Medicine","Cognitive Behavioral Therapy",[156,157,158,159,160,161],"Ovarian Cancer","Cancer-Related Insomnia","Traditional Chinese Medicine","Cognitive Behavioral Therapy for Insomnia","Randomized Controlled Trial","Progression-Free Survival","2026-04-19",{"date":164,"type":36},"2026-04-24",{"date":98,"type":20},{"date":167,"type":20},"2029-09-30",{"name":169,"class":43},"Shanghai Municipal Hospital of Traditional Chinese Medicine",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":111,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100615655","sleep-efficacy-randomized-evaluation-of-a-novel-digital-therapeutic-for-insomnia-100615655","NCT07295431","Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia","A Multicenter, Randomized, Double-Blind, Sham-Controlled, Pivotal Clinical Investigation to Evaluate the Efficacy and Safety of the Digital Therapeutic 'BELL-001' for Improving Symptoms in Patients With Insomnia","SERENE","Inclusion Criteria:\n\n* Adults aged 19 to 75 years.\n* Clinical diagnosis of insomnia disorder according to ICD-11 criteria (non-organic insomnia or sleep initiation\u002Fmaintenance disorder).\n* Insomnia Severity Index (ISI) score ≥ 15 at screening.\n* Reports difficulty initiating or maintaining sleep at least 3 nights per week for ≥ 3 months.\n* Willing and able to use a smartphone-based digital therapeutic during the pre-sleep period for 4 weeks.\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Other primary sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders).\n* Major psychiatric disorders that may interfere with study assessment (e.g., psychotic disorders, bipolar disorder, severe major depressive episode).\n* Substance use disorder, including alcohol or hypnotic misuse, within the past 12 months.\n* Use of sleep-inducing medications or CNS-active drugs that cannot be stabilized or discontinued per protocol.\n* Significant medical or neurological conditions that may affect sleep or study outcomes (e.g., severe cardiovascular, respiratory, or neurological disease).\n* Night-shift workers or individuals with irregular sleep-wake schedules.\n* Pregnancy or breastfeeding.\n* Participation in another interventional clinical study within the past 30 days.\n* Any condition judged by the investigator to interfere with study participation, safety, or data validity.",{"count":179,"type":20},114,[55],"This study is a multicenter, randomized, double-blind, sham-controlled clinical investigation designed to evaluate the effectiveness and safety of BELL-001, a digital therapeutic developed to improve symptoms of insomnia. Insomnia is a common sleep disorder that can significantly affect daytime functioning, mood, and overall quality of life. Many patients continue to have difficulties despite lifestyle changes or medication, and safer, non-pharmacological treatment options are increasingly needed.\n\nBELL-001 is a smartphone-based therapeutic that delivers personalized auditory stimulation during the pre-sleep period. The device is intended to promote relaxation and support the transition into sleep by analyzing individual breathing patterns and providing synchronized sound feedback. The study will compare BELL-001 with a sham (placebo-like) digital device that looks identical but does not provide the active therapeutic functions.\n\nAdults diagnosed with insomnia will be randomly assigned to either the BELL-001 group or the sham group. Participants will use the assigned device for four weeks. Throughout the study, sleep-related symptoms, daytime functioning, fatigue, and quality-of-life measures will be assessed. The primary outcome is the change in Insomnia Severity Index (ISI) scores after four weeks of treatment. Safety will be monitored regularly through participant reports and clinical evaluations.\n\nThis trial is being conducted at multiple hospitals in Korea and follows ethical guidelines, including review and approval by institutional review boards (IRBs). Participation is voluntary, and all individuals will provide informed consent before any study procedures begin. The results of this study are expected to provide key evidence for the clinical use of a digital, non-pharmacological intervention for adults with insomnia.",[28,27],[184,118,120,121,122,185,186,123,124],"Digital Therapeutic","Sleep Onset Latency","Sham-Controlled Trial","2025-12-18",{"date":189,"type":36},"2025-12-22",{"date":191,"type":20},"2026-01-15",{"date":193,"type":20},"2026-07-31",{"name":133,"class":134},6,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":44},"100521249","sleep-for-health-study-on-the-effects-of-cognitive-behavioral-therapy-for-insomnia-on-diabetes-risk-100521249","NCT06067139","Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk","Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk","Inclusion Criteria:\n\n* Age ≥ 22 years and \\\u003C 80 years of age\n* Prediabetes\n* Insomnia\n* Regular access to device with internet access\n* Adequate data at baseline\n\nExclusion Criteria:\n\n* BMI \\> 40 kg\u002Fm2\n* Sleep comorbidities detected in medical record or via medical history\n* Shift work or significant, externally imposed irregular sleep schedule\n* moderate to severe OSA by home sleep apnea test as part of trial protocol\n* Received a full course of CBT-I in the last 12 months\n* Current use of medication with glycemic effects:\n* History of type 1 or type 2 diabetes or recent\u002Fplanned use of hypoglycemic agents (e.g., metformin, insulin)\n* Recent history of bariatric surgery or planning bariatric surgery in the next year\n* Current or recent use of weight loss meds\n* Unstable sleep medication regimen (recent change to schedule or dosage)\n* Significant comorbidity that may interfere with CBT-I uptake or increase risks\n* Unwilling or unable to limit heavy machinery use\u002Flong bouts of driving or unstable illness that would be worsened by sleep restriction\n* High risk of falls\n* Epilepsy\n* Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)\n* Significant alcohol or substance use disorder\n* Active or recent history of eating disorder, recent weight change of \\>10%\n* Women: pregnancy (current or planned), breastfeeding, \\\u003C 1 year postpartum\n* Use of hydroxyurea\n* Extensive skin changes or adhesive allergy making CGM sensor use problematic","22 Years","79 Years",{"count":206,"type":20},300,[55],"This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.",[210,211,27],"Diabetes Mellitus, Type 2","Prediabetic State","2025-12-11",{"date":214,"type":36},"2025-12-15",{"date":216,"type":36},"2023-08-01",{"date":218,"type":20},"2027-12",{"name":220,"class":43},"Kaiser Permanente",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},"100335024","phase-4-suvorexant-a-dual-orexin-receptor-antagonist-for-treating-sleep-disturbance-in-posttraumatic-stress-100335024","NCT03642028","Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress","Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance inPosttraumatic Stress","Inclusion Criteria:\n\n* Men and Women, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide written informed consent\n* Criterion A event meets DSM-5 criteria\n* PTSD symptoms \\>3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening\n* Insomnia indicated by an ISI score \\> 14\n* Subjects on non-exclusionary medications must be on a stable dose for at least 4 weeks prior to randomization, which includes the Selective Serotonin Reuptake Inhibitors (SSRIs) e.g.:\n\n  * Sertraline\n  * Paroxetine\n  * Fluoxetine\n  * Fluvoxamine\n  * Citalopram\n  * Escitalopram\n* Serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g.:\n\n  * Desvenlafaxine\n  * Duloxetine\n  * Levomilnacipran\n  * Venlafaxine\n* For subjects who are in psychotherapy, treatment must be stable for 6 weeks\n* Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control, e.g.:\n\n  * oral\n  * implantable\n  * injectable\n  * transdermal contraceptive\n  * intrauterine device\n  * double-barrier method\n* Sleep apnea score \\\u003C30; if screening indicates mild or moderate sleep apnea (score between 5 and 30), referral will be provided\n\nExclusion Criteria:\n\n* DSM-5 alcohol, marijuana, and\u002For other drug use disorder in the last 3 months\n\n  * Mild alcohol use not meeting criteria for moderate or severe use disorder may be allowed on a case-by-case basis\n  * Mild or moderate marijuana use disorder may be allowed on a on a case-by-case basis\n* Manic or psychotic episode in the last 5 years\n* Exposure to trauma in the last 3 months\n* Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS) or increased risk of suicide that necessitates additional therapy or inpatient treatment\n* Pre-existing severe sleep apnea (score \\>30) in the absence of adherence to effective treatment (such as CPAP or oral device) or positive screen for severe sleep apnea by type III device (score \\> 30)\n* Neurologic disorder or systemic illness affecting CNS function\n* Chronic or unstable medical illness including:\n\n  * unstable angina\n  * myocardial infarction within the past 6 months\n  * congestive heart failure\n  * preexisting hypotension or orthostatic hypotension\n  * heart block or arrhythmia\n  * chronic renal or hepatic failure\n  * pancreatitis\n  * severe chronic obstructive pulmonary disease\n* History of severe traumatic brain injury\n* Mild cognitive impairment assessed by the Montreal Cognitive Assessment\n* Pregnancy, breastfeeding and\u002For refusal to use effective birth control (for women)\n* Narcolepsy\n* Previous adverse reaction to a hypnotic\n* Current use of benzodiazepines, strong CYP3A inhibitors, or Digoxin\n\nProhibited:\n\n* benzodiazepines\n* strong CYP3A inhibitors\n* Digoxin\n* Furthermore, CNS depressants (e.g., benzodiazepines, opioids, alcohol) increase the risk of CNS depression when co-administered with suvorexant and will not be allowed for safety reasons.\n* Since metabolism by CYP3A is the major elimination pathway for suvorexant, concomitant use of suvorexant with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan), moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil), or strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin) will not be allowed.\n* All concomitant medication use will be monitored and documented",{"count":229,"type":20},190,[231],"PHASE4","Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.",[27,234],"Stress Disorders, Posttraumatic",[27,234,236,61],"Suvorexant","2025-07-17",{"date":239,"type":36},"2025-07-18",{"date":241,"type":36},"2019-08-30",{"date":243,"type":20},"2025-12-31",{"name":73,"class":74},4,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100437778","grain-moxibustion-treatment-on-insomnia-a-randomized-controlled-trial-100437778","NCT04980703","Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of insomnia;\n2. TCM syndrome differentiation belongs to deficiency of both heart and spleen;\n3. Male or female participants aged 18-75;\n4. Participants whose PSQI score is 5-15;\n5. The course of disease is more than 3 months;\n6. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.\n\nExclusion Criteria:\n\n1. Participants with mental retardation;\n2. Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;\n3. Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);\n4. Female participants who is pregnant or lactating;\n5. Participants with diabetes and sensory dysfunction.\n6. Participants with skin diseases of acupoints;\n7. Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;\n8. Participants with dependence on sleeping drugs;\n9. Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.",{"count":253,"type":20},102,[55],"This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia.",[27],[258,259],"moxibustion","insomnia","2025-05-13",{"date":262,"type":36},"2025-05-14",{"date":264,"type":20},"2027-07-01",{"date":266,"type":20},"2029-07-31",{"name":268,"class":43},"Shanghai Institute of Acupuncture, Moxibustion and Meridian",2,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":44},"100439302","evaluation-of-the-effectiveness-of-patient-therapeutic-education-on-chronic-insomnia-100439302","NCT05000528","Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia","Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique","ETP-INSOMNIE","Inclusion Criteria:\n\n* The patient must have given their free and informed consent\n* The patient must be a member or beneficiary of a health insurance plan\n* Patient must understand and read French\n* Patient with ICSD-3 diagnostic criteria for chronic insomnia: ISI score \\> 14\u002F28.\n\nExclusion Criteria:\n\n* Patient with cognitive impairment as assessed by the investigator\n* Patient with shift work\n* Patients scoring \\> 10\u002F24 on the Epworth sleepiness scale\n* Patient suffering from medical or psychiatric illnesses which may, in the opinion of the investigator, compromise the subject's state of health or ability to participate in the study.\n* Patient with chronic alcohol consumption or drug abuse\n* Patient unable to express consent.\n* Pregnant, parturient or breastfeeding patient.\n* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship",{"count":279,"type":20},44,[55],"20 to 30% of the general population suffers from chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment, but unfortunately its implementation is complex. Long waiting times for a consultation \u002F exploration, too short a consultation period, non-reimbursement of specialists and a lack of trained staff make the current care of insomniac patients difficult. Patients are thus treated late, often with heavy drug treatment, dependence on sleeping pills, difficult withdrawal and \u002F or reactive mood disorders. The treatment is therefore limited to advice on sleep hygiene and a restriction of time spent in bed without ultimately intervening in the cognitive domain. Therapeutic education consists of empowering the patient in the management of chronic insomnia through group education workshops. The patient learns the principles of normal sleep, the way in which sleep evolves with aging, the dangers of treatments as well as the rules of sleep hygiene and the behaviors to modify to sleep well. In addition to benefiting from sharing of experience with other patients, therapeutic education makes the care pathway smoother and considerably reduces the long waiting times of the traditional care pathway in consultation.\n\nThe study investigators hypothesize that therapeutic education is more effective as a treatment for chronic insomnia than traditional management in individualized consultation (IC). Thus, therapeutic education could constitute an effective alternative to CBT.",[27],"2024-12-13",{"date":285,"type":36},"2024-12-18",{"date":287,"type":36},"2022-09-30",{"date":289,"type":20},"2025-09-29",{"name":291,"class":43},"Centre Hospitalier Universitaire de Nīmes",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":16,"minAge":299,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":312,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":44},"100482730","phase-2-sleep-healthy-using-the-internet-mitigating-insomnia-to-address-neurocognitive-difficulties-shuti-mind-100482730","NCT05565833","Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)","Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥ 65 years of age.\n* Able to speak and read English, and is a US resident.\n* Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.\n* Sleep-onset insomnia and\u002For sleep maintenance insomnia symptoms\n* The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months.\n* Cognitive impairment through study assessment.\n* Stable medication regimen unless medication is known to cause insomnia\n\nExclusion Criteria:\n\n* Current psychological treatment for insomnia\n* Initiation of psychological or psychiatric treatment within the past three months\n* Current diagnosis of Huntington's or Parkinson's disease\n* Current treatment for hyperthyroidism\n* Currently undergoing chemotherapy\n* Presence of asthma or respiratory concerns with night treatment\n* Chronic pain treated with opioids\n* Not recovered from a brain tumor, injury, or infection\n* Epilepsy without stable treatment for at least 3 months\n* Irregular sleep schedule\n* Use of stimulating medications after 5pm or taken for less than 3 months\n* Psychotic or bipolar disorder\n* Moderate to high risk of suicide\n* Alcohol or drug abuse within the past year\n* Other untreated sleep disorders (e.g., obstructive sleep apnea)\n* Study screen for severe depression","65 Years",{"count":301,"type":20},144,[24],"This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.",[28,305,306,27,307,308,309,310,311],"Cognitive Dysfunction","Mild Cognitive Impairment","Sleep Disorders, Intrinsic","Dyssomnias","Sleep Wake Disorders","Nervous System Diseases","Alzheimer Disease",[28,313,314,315],"Alzheimer's disease","Mild cognitive impairment","Cognitive behavioral therapy","2024-05-06",{"date":318,"type":36},"2024-05-08",{"date":320,"type":36},"2023-02-27",{"date":322,"type":20},"2028-01",{"name":324,"class":43},"University of Virginia"]