[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insomnia-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insomnia-chronic":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,46,75,103,130,164,184,210,232,256,285,314,339,369,396,419,445,469,488,515,535,553,583,613,635],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29,30,31,32],"Sleep Initiation and Maintenance Disorders","Insomnia","Insomnia Chronic","Mindfulness","Telemedicine","RECRUITING","2026-06-21",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2026-03-31",{"date":41,"type":21},"2028-12-29",{"name":43,"class":44},"Brigham and Women's Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100411062","web-based-cognitive-behavioral-treatment-for-insomnia-in-dementia-caregivers-100411062","NCT04632628","Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers","NiteCAPP","CAREGIVER\n\nInclusion Criteria:\n\n* 18+ yrs\n* Dementia caregiver living with person with dementia\n* willing to be randomized, 4. read\u002Funderstand English\n* insomnia diagnosis\n* no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.\n\nInsomnia:\n\n* complaints for 6+ mos\n* adequate opportunity and circumstances for sleep\n* 1+ of the following: difficulty falling asleep, staying asleep, or waking too early\n* daytime dysfunction (mood, cognitive, social, occupational) due to insomnia\n* Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10\n* baseline diaries indicate \\>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.\n\nExclusion Criteria:\n\n* unable to consent\n* cognitive impairment \\[Telephone Interview for Cognitive Status (TICS) \\\u003C25 or Mini Mental State Examination (MMSE) \\\u003C26\\]\n* sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea index, AHI \\>15)\\]\n* bipolar or seizure disorder\n* other major psychopathology except depression or anxiety (e.g., suicidal ideation\u002Fintent, psychosis)\n* severe untreated psychiatric comorbidity\n* psychotropic or other medications (e.g., beta-blockers) that alter sleep\n* non-pharmacological tx for sleep or mood outside current trial.\n\nPERSONS WITH DEMENTIA\n\nInclusion Criteria:\n\n* 18+ yrs\n* Persons with dementia living with caregiver\n* Have an eligible caregiver\n* willing to be randomized\n\nExclusion Criteria:\n\n• Person with dementia or legally authorized representative is unable to consent",true,{"count":55,"type":21},60,[57],"NA","Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.\n\nObjectives\n\n1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.\n2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.\n3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.\n4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).",[30,60],"Dementia",[62,63,64,65,29,60],"Dementia Caregiver","Sleep","Behavioral Interventions","Online Behavioral Intervention","2026-06-11",{"date":68,"type":37},"2026-06-15",{"date":70,"type":37},"2023-11-14",{"date":72,"type":21},"2027-09-30",{"name":74,"class":44},"University of South Florida",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"100527554","treatment-of-insomnia-in-primary-care-study-100527554","NCT06149273","Treatment of Insomnia in Primary Care Study","TIP","Inclusion Criteria:\n\n* Insomnia severity index (ISI) score at least 8\n* insomnia symptoms present at least for 3 months\n\nExclusion Criteria:\n\n* diagnosed dementia based on medical records\n* acute suicidality\n* acute psychotic symptoms",{"count":83,"type":21},250,[57],"The goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia.\n\nThe main question it aims to answer is:\n\n• Does Sleep School (a therapy for insomnia) work well to decrease harm of insomnia? Participants will attend a group therapy intervention once a week for six weeks.\n\nResearchers will compare Sleep School to treatment as usual (short counselling by an educated nurse) to see if the Sleep School works better than treatment as usual in decreasing the harm of insomnia.",[30],[88,89,90,91,92,93],"Cognitive behavioral therapy for insomnia","CBT-I","Primary care","Insomnia severity index","Quality of life","Depressive symptoms","2026-04-30",{"date":96,"type":37},"2026-05-01",{"date":98,"type":37},"2023-12-02",{"date":100,"type":21},"2029-12",{"name":102,"class":44},"University of Turku",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":45},"100564963","aerobic-exercise-versus-digital-cognitive-behavioral-therapy-for-insomnia-100564963","NCT06636006","Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia","Effects of Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia in University Students With Insomnia Complaints","Inclusion Criteria:\n\n* ages ≥ 18 years old\n* insomnia severity index score \\>8\n* be physically inactive according to the IPAQ questionnaire\n\nExclusion criteria:\n\n* non-adherence to intervention protocols\n* absence or incomplete answers in the questionnaires\u002Fevaluation methods of the study\n* shift workers",{"count":111,"type":21},50,[57],"The purpose of this study is to compare the effects of aerobic exercise versus digital CBT-I in university students with insomnia complaints. This is a clinical trial. Participants will be randomized into two groups: aerobic exercise (n=25) and digital CBT-I (n=25). The severity of insomnia, sleep quality, pre-sleep cognitive and somatic arousal, and participants' complaints of depression, anxiety, and stress will be assessed using self-administered questionnaires. Based on previous studies describing the effects of physical exercise on chronic insomnia, the hypothesis of this study is that aerobic exercise promotes similar results compared to digital CBT-I in insomnia severity and sleep quality, in addition to improving the complaints of depression, anxiety and stress of the participants.",[30],[116,117,118,119,120],"chronic insomnia","exercise","sleep","anxiety","depression","2026-04-23",{"date":123,"type":37},"2026-04-24",{"date":125,"type":37},"2024-10-10",{"date":127,"type":21},"2027-12-30",{"name":129,"class":44},"Universidade Federal de Goias",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100635726","effective-of-early-treatment-of-insomnia-on-the-adherence-of-cpap-100635726","NCT07556432","Effective of Early Treatment of Insomnia on the Adherence of CPAP","Comorbid Insomnia and Sleep Apnea (COMISA): Can Early Treatment of Insomnia Improve Adherence to CPAP Therapy?","CoPAP","Inclusion criteria:\n\n1. 45-65 years of age\n2. Diagnosis of OSAS by respiratory polygraphy or polysomnography with an apnea-hypopnea index (AHI) ≥20 when scored by PSG or ≥15 when scored by PG30 with a prescription for CPAP therapy\n3. Diagnosis of chronic insomnia according to the International Classification of Sleep Disorders (ICSD 3-TR).31\n4. Ability to communicate in French\n5. Ability to provide informed consent\n6. Accept to receive information about incidental findings\n7. Ownership of a smartphone running at least Android 9 (API version 28+) or iOS 12.2+.\n\nExclusion criteria:\n\n1. Current treatment for OSAS\n2. Current or past treatment for chronic insomnia (CBT-I)\n3. Severe restless legs syndrome\n4. REM sleep behaviour disorder\n5. Neurological diseases (stroke, Parkinson's disease, etc.)\n6. Severe hypertension (≥180 mmHg systolic or requiring ≥3 antihypertensive medications)\n7. Respiratory failure (oxygen saturation during wakefulness \\\u003C90%)\n8. Severe heart failure (NYHA class III-IV)\n9. High-risk alcohol consumption (≥14 units\u002Fweek)\n10. Known pregnancy\n11. Epilepsy or history of epileptic seizures (ICD-11: 8A6; ICD-10: G40)\n12. Known bipolar disorder of any type (ICD-11: 6A60, 6A61, 6A6Y, 6A6Z; ICD-10: F31)\n13. Known Acute and transient psychotic disorder (ICD-11: 6A23; ICD-10: F23)\n14. Known Active suicidal ideation\n15. Known or suspected severe parasomnias incompatible with programme use (e.g., sleepwalking:\n16. Known Severe cardiovascular disease that may contraindicate unsupervised CBT-I strategies (e.g., unstable arrhythmias, angina pectoris)\n17. Any medical or psychiatric condition that, in the investigator's judgment, would contraindicate the use of the CE-marked HelloBetter Insomnie digital device or participation in CBT-I","45 Years","65 Years",{"count":141,"type":21},120,[57],"This study includes patients suffering from both sleep apnea and insomnia. All participants receive treatment with CPAP. Half of the participants additionally receive a digital program to treat insomnia, initiated at the same time as CPAP. The other half follows usual care and will be able to access the program after 6 months. The aim is to determine whether treating insomnia earlier improves CPAP use and overall health.",[145,30],"Obstructive Sleep Apnea (OSA)",[147,148,149,150,151,152,153],"Obstructive sleep apnea","OSA","CPAP","COMISA","cognitve behavorial therapy for insomnia","cognitive health","cardiovascular health","NOT_YET_RECRUITING","2026-04-22",{"date":157,"type":37},"2026-04-29",{"date":159,"type":21},"2026-06-01",{"date":161,"type":21},"2028-12-31",{"name":163,"class":44},"Centre Hospitalier Universitaire Vaudois",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":45},"100578114","efficacy-of-synchronous-virtual-cognitive-behavioral-therapy-for-insomnia-across-phases-of-cancer-survivorship-100578114","NCT06807086","Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship","Inclusion Criteria:\n\n1. Cancer survivor, defined as:\n\n   1. (A) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and completion of primary cancer treatment (i.e., radiation, surgery, and\u002For chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted; or\n   2. (B) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and current primary cancer treatment (i.e., radiation, surgery, and\u002For chemotherapy); Use of hormonal, maintenance, oral, and immunotherapies is permitted; or\n   3. (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression.\n2. Chronic insomnia (DSM-5 criteria)\n3. Age 18 years or older\n\nExclusion Criteria:\n\n1. Self-reported inability to speak and write in English\n2. Undertreated non-insomnia sleep disorder (e.g., sleep apnea)\n3. Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and\u002For psychiatric hospitalization in the past year\n4. Unwilling or unable to discontinue night shift work",{"count":171,"type":21},198,[57],"This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications.\n\nNotably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1).\n\nThis project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation.\n\nCollectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.",[30],"2026-03-11",{"date":177,"type":37},"2026-03-13",{"date":179,"type":37},"2025-01-01",{"date":181,"type":21},"2028-12-28",{"name":183,"class":44},"Massachusetts General Hospital",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":45},"100622729","sleep-learning-education-and-empowerment-for-older-korean-immigrants-100622729","NCT07387406","Sleep Learning Education and Empowerment for Older Korean Immigrants","A Culturally Adapted Sleep Intervention Program for Older Asian Immigrants With Limited English Proficiency","SLEEP-OK","Inclusion Criteria:\n\n* Korean immigrants (i.e., being a resident of the United States with a birthplace in Korea)\n* Able to speak, read, and write in Korean\n* Aged at least 60 years\n* Have a score of at least 15 on a Korean version of the Insomnia Severity Index\n* Able to ambulate with or without an assistive device\n* Have a score of at least 23 on a Korean version of the Montreal Cognitive Assessment (MoCA)\n* Score less than 5 on STOP-BANG (or proceed with an additional testing \\[Watch Peripheral Arterial Tonometry (WatchPAT) and the Epworth Sleepiness Scale if score is equal to or greater than 5 on STOP-BANG)\n\nExclusion Criteria:\n\n* Those who are bedbound\n* Those who do not meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder\n* Those who have an untreated apnea-hypopnea index (AHI) at least 15 (moderate obstructive sleep apnea) and Epworth Sleepiness Scale (ESS) at least 11 (indicating mild sleepiness) OR AHI is equal to or greater than 30 (irrespective of ESS)","60 Years",{"count":194,"type":21},32,[57],"Poor sleep is common among Asian Americans. Untreated sleep problems increase the risk of chronic diseases, cognitive decline, and mortality. Cognitive behavioral therapy for insomnia (CBTI) is considered the first-line treatment for chronic sleep problems and has demonstrated significant improvement in sleep health among older adults. However, existing CBTI is built upon Western culture, making it challenging to apply for Asian immigrants who maintain close ties to their native cultures that shape and influence their sleep habits. Addressing the lack of availability of a culturally adapted sleep intervention program is the first step to filling the gap in sleep health disparity among Asian immigrants.\n\nThis study aims to pilot test the feasibility and the preliminary efficacy of a culturally adapted sleep intervention program among older Korean immigrants with poor sleep, one of the fastest-growing immigrant groups in the United States with limited access to mainstream sleep therapies.",[30],[199,118,200],"older Korean Americans","behavioral approach","2026-03-03",{"date":203,"type":37},"2026-03-05",{"date":205,"type":37},"2026-02-24",{"date":207,"type":21},"2027-01-04",{"name":209,"class":44},"University of California, Los Angeles",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":45},"100599846","nurse-supported-mobile-app-for-self-help-cbt-i-in-informal-cancer-caregivers-100599846","NCT07089797","Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers","Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years\n* Informal caregiver (e.g., family member or a friend) who co-resides with a cancer survivor of any site or stage and provides at least 4 hours of unpaid daily care. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.\n* Able to understand the research procedures, and read and communicate in Chinese\n* Able to use WeChat\n* Insomnia severity index scores \\> 7\n\nExclusion Criteria:\n\n* Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated\n* Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months\n* Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)\n* Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy\n* Currently participating in any other interventional program\n* Prior experience with CBT-I\n* Night, evening, early morning or rotating shift work\n* Currently caring for a cancer patient receiving hospice care",{"count":218,"type":21},208,[57],"This mixed-methods randomized controlled trial investigates whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) effectively reduces insomnia severity among informal cancer caregivers, compared to sleep hygiene education.\\\u003Cbr\\>\\\u003Cbr\\>\n\nThe primary research question is:\\\u003Cbr\\> Does nurse-supported mobile app for self-help CBT-I lower insomnia severity among cancer caregivers compared to sleep hygiene education at post-intervention and 3-month follow-up?\\\u003Cbr\\>\\\u003Cbr\\>\n\nA total of 208 participants will:\\\u003Cbr\\>\n\n1. Be randomly assigned to one of two groups:\\\u003Cbr\\> (i) the nurse-supported mobile app-based self-help CBT-I group, which involves a 6-week CBT-I program delivered via a WeChat mini program along with weekly nurse support sessions (up to 20 minutes each); or\\\u003Cbr\\> (ii) the sleep hygiene education group.\\\u003Cbr\\>\n2. Complete assessments at baseline, post-intervention, and 3-month follow-up to measure changes in insomnia severity (primary outcome). Secondary outcomes include subjective sleep outcomes, psychological well-being, caregiver burden, fatigue, health-related quality of life, and participants' acceptability and satisfaction.\\\u003Cbr\\>\\\u003Cbr\\>\n\nAs recommended for trials of complex interventions, investigators will conduct a process evaluation in alignment with the Medical Research Council (MRC) guidance. The key functions of the process evaluation include: \\*(1) implementation, (2) mechanisms of impact, and (3) context.\\*",[30,222],"Cancer Caregivers","2026-02-13",{"date":225,"type":37},"2026-02-18",{"date":227,"type":37},"2025-08-11",{"date":229,"type":21},"2026-08-01",{"name":231,"class":44},"The University of Hong Kong",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":45},"100625298","phase-2-efficacy-and-safety-of-apstzd-in-the-treatment-of-insomnia-disorder-100625298","NCT07420816","Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder","Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder","TINA","Inclusion Criteria:\n\n* Participants aged between 18 and 64 years;\n* Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;\n* Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).\n\nExclusion Criteria:\n\n* Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;\n* Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;\n* Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;\n* Participants diagnosed with severe liver failure;","64 Years",{"count":242,"type":21},222,[25],"The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.",[29,30],"2026-02-12",{"date":248,"type":37},"2026-02-19",{"date":250,"type":21},"2026-03-26",{"date":252,"type":21},"2027-09-23",{"name":254,"class":255},"Apsen Farmaceutica S.A.","INDUSTRY",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":139,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":45},"100617248","phase-2-deep-sleep-in-older-adults-100617248","NCT07316153","Deep Sleep in Older Adults","An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia That Improves Cognition in Older Adults","Inclusion Criteria\n\n1. Fluent English speaker and reader.\n2. Capable of providing one's own informed consent.\n\n   1. As determined by validated, abbreviated phone-based remote Montreal Cognitive Assessment (MoCA) testing score of ≥18, which is the score that separates Mild Cognitive Impairment (MCI) from Alzheimer's Disease and Related Dementia (ADRD).\n3. Age 65+ years old (inclusive) at enrollment, but if recruitment is slow, the investigators may adjust the criteria to 60+, and if it is still slow, it could go as low as 55+ years old.\n\n   1. As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)\n4. If residing in a community residence (such as a retirement community) in which a Medical Director designates living status categories, then the participant must be Independent Living status (or equivalent).\n\n   a. As self-reported on screening survey\n5. Insomnia Severity Index score ≥15 (i.e., at least \"clinical insomnia,\" that is \"moderate-to-severe\") - but if recruitment is slow then the investigators will recruit with ISI score ≥11 \"mild-to-severe\").\n\n   a. As self-reported on the ISI screening survey\n6. Willing to refrain from initiating new therapeutic interventions (e.g. medication; behavioral) that are not a part of this study protocol for issues pertaining to sleep for the duration of study participation.\n\n   1. By self-report\n7. Willing to maintain any existing physician-directed pharmacologic intervention for issues pertaining to sleep for the duration of study participation.\n\n   a. By self-report\n8. Has a residence with WIFI.\n\n   a. By self-report\n9. Normal hearing with or without a hearing aid.\n\n   a. By self-report\n10. Difficulty falling asleep, staying asleep, or waking too early, occurring at least 3 nights\u002Fweek for 3+months, causing significant daytime distress\u002Fimpairment (e.g., fatigue, poor focus, mood issues), despite adequate sleep opportunity, and not better explained by another sleep disorder or substance.\n\n    1. By Sleep Condition Indicator \\[SCI\\]\n\nExclusion Criteria\n\n1. Illicit drug use in the past month (except for marijuana because it is legal in many States, and the investigators are recruiting nationwide).\n\n   a. As self-reported on screening survey. Marijuana usage will be tracked via self-report and examined as a moderator.\n2. Diagnosed serious mental health disorder.\n\n   1. Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia\n   2. As self-reported on screening survey\n3. Currently or recent engaged (past 1-year) in evidence-based psychotherapy for Insomnia (e.g., CBTi), in addition to ever receiving a full course of CBTi:\n\n   a. By self-report\n4. Cohabitating with a current or previous participant in this study.\n\n   a. This criterion is to avoid cross-contamination of study condition awareness, if two cohabitating individuals are randomized into different study arms.\n5. Initiation of any psychological treatment in the last 3-months.\n6. A highly irregular schedule (e.g. shift work) that would prevent adoption of intervention strategies, as evaluated through the Shift Work Disorder Index.\n7. Previous exposure to the SleepSpace software.\n8. Medical conditions that are exacerbated by sleep restriction.\n9. Planned major surgery during the trial.",{"count":264,"type":21},180,[25],"This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (CBT-I +Internet of Things \\[IoT\\]+Artificial Intelligence \\[AI\\]). With this approach, the investigators aim to overcome many of the limitations that CBT-I in the clinic faces: the investigators can implement it in ambulatory settings while providing increased (remote) accessibility to therapy. The investigators will compare the CBT-I +IoT+AI to active controls that also integrate with smart phone devices, including SleepEZ, which is also based on CBT-I, and sleep hygiene education. These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) (primary outcome), sleep metrics (secondary outcome), cognitive performance (secondary outcome), and additional outcomes like therapeutic adherence and other mental health assessments. Participants will be asked to track sleep with wearable and nearable devices, complete surveys, and complete cognitive assessments.",[29,30],[269,270,271,272,273,274,275],"cognitive behavioral therapy","internet of things","wearables","insomnia","older adults","cognitive impairment","cognition","2025-12-31",{"date":278,"type":37},"2026-01-05",{"date":280,"type":21},"2026-03-01",{"date":282,"type":21},"2026-12-30",{"name":284,"class":255},"Proactive Life Inc",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":139,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":45},"100591642","phase-2-efficacy-of-trazodone-to-treat-insomnia-in-older-adults-tradition-study-100591642","NCT06983080","Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)","The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)","TRADITION","Inclusion Criteria:\n\n* Individuals aged 65 or older in an outpatient setting\n* Insomnia according to the criteria of the ICSD-3R\n\nExclusion Criteria:\n\n* Contraindication to trazodone (hypersensitivity)\n* Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes)\n* Recent myocardial infarction (\\\u003C 6 months)\n* Substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs)\n* Active, unstable psychiatric disorder\n* Initiation or titration of an antidepressant within the past 6 months\n* Cognitive-behavioral therapy ongoing or planned during the study period\n* Major neurocognitive disorder (NCD) moderate or severe, or other cognitive disorders that may prevent the participant from being able to participate in the study, according to the judgment of the evaluating physician\n* Parkinson's disease\n* Priapism\n* Known angle-closure glaucoma\n* Symptomatic restless leg syndrome \\> 3 times per week\n* QTc interval \\> 500 ms\n* Parasomnias, dyssomnias other than insomnia\n* Severe sleep apnea with AHI \\> 30 without CPAP treatment\n* Use of a monoamine oxidase inhibitor\n* Use of a strong CYP 3A4 inducer or inhibitor\n* Hospitalized individuals\n* Seizure within the past 6 months\n* History of orthostatic hypotension\n* History of delirium within the last 6 months\n* Consumption of \\> 14 alcoholic drinks per day or use of alcohol to induce sleep.",{"count":294,"type":21},40,[25],"This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is :\n\n\\- Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults?\n\nParticipants will :\n\n* Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days.\n* Visit the clinic three times for checkup and test\n* Complete a sleep diary and wear an actimeter during the night.",[30,298,299],"Older People","Drug Therapy",[301,302,303,304],"insomia","Trazodone","Older adults","randomized controlled trial","2025-12-02",{"date":307,"type":37},"2025-12-08",{"date":309,"type":37},"2025-11-10",{"date":311,"type":21},"2027-12",{"name":313,"class":44},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":138,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":45},"100559674","the-effects-of-insomnia-treatment-on-overnight-regulation-of-emotional-memories-and-risk-for-mental-disorders-100559674","NCT06567210","The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders","A Delayed-start Randomized Controlled Trial Comparing the Effects of Online Therapist-guided Cognitive Behavioural and Circadian Therapy for Insomnia Versus Control on Overnight Emotion Regulation and Mental Health Outcomes","Restless","Inclusion Criteria:\n\n* (A or B) and (C) A. Diagnosis of insomnia disorder (DSM-5-TR) B. Insomnia Severity Index (ISI) score ≥ 10 C. Generalized Anxiety Disorder (GAD-7) score ≥ 10\n* All sexes and genders.\n* Between 18 and 45 years of age.\n* Able to provide informed consent.\n* Proficient in English.\n\nExclusion Criteria:\n\nx Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder, moderate to severe sleep apnoea disorder based on previous sleep study with an apnea-hypopnea index ≥ 15 and\u002For finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10).\n\n* Current or history of neurological disorders (e.g., stroke, brain injury).\n* Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder.\n* Current uncontrolled mental health disorders requiring specialist care, other than major depression and anxiety disorders.\n* Centrally active agents or presence of medical condition that may affect participation.\n* Pregnancy or actively trying to conceive, or lactating.\n* Shift work for at least 2 shifts per week in the past 3 months (i.e., work between 21:00 and 6:00).\n* Travel across time zones over 3 hours difference in the previous 30 days (will require a 1-day adjustment period per hour of time zone travelled).\n* Unwilling to know about potential incidental findings.\n* No consent or adherence to instructions for any part of the study protocol.",{"count":323,"type":21},98,[57],"This project aims to elucidate whether CBCTi changes symptom severity or even remission of anxiety disorders as compared with a delayed-start control group. The investigators will use a delayed-start randomized controlled trial in a cohort of individuals with anxiety and insomnia (N=98) to compare the effects of an online therapist-guided cognitive behavioural and circadian therapy for insomnia versus control on overnight emotion regulation and mental health outcomes.\n\nThe project will involve at-home assessments and in-lab visits. At-home assessment involves recording sleep and circadian rhythm measures with wearables and daily diaries. Participants will be invited to perform two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.",[30,327],"Anxiety",[272,119,329],"online cognitive behavioral and circadian therapy for insomnia","2025-11-20",{"date":332,"type":37},"2025-11-26",{"date":334,"type":21},"2026-01-06",{"date":336,"type":21},"2030-06",{"name":338,"class":44},"Woolcock Institute of Medical Research",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":45},"100605836","sleep-difficulties-after-loss-exploring-the-beneficial-effect-of-brief-behavioral-therapy-for-insomnia-in-a-sample-of-bereaved-individuals-100605836","NCT07167706","Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals","Sleep Difficulties After Loss (SLEEPLOSS): Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals","SLEEPLOSS","Inclusion Criteria:\n\n* Age ≥18 years\n* Bereaved (experienced the death of a perceived loved one) ≥6 months ago\n* Insomnia: a score of \\>10 on the Insomnia Severity index (ISI) and\u002For meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder\n\nExclusion Criteria:\n\n* Other sleep disor-ders (sleep apnea, parasomnia, narcolepsy)\n* Use of drugs impacting sleep\n* Severe psychological or physical disorders that may confound sleep (symptoms of CGR allowed)\n* Neurodegenerative disorders\n* Shift work\n* Insufficient Danish proficiency\n* Previous experience with BBTI or cognitive behavioral therapy for insomnia (CBT-I)",{"count":348,"type":21},58,[57],"The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened for insomnia compared to an active control group (sleep hygiene education). The study will also explore if BBTI improves symptoms of complicated grief. The investigators will recruit approximately 58 bereaved participants with insomnia.",[29,30,352],"Complicated Grief",[29,30,354,355,63,356,352,357,358,359],"Brief Behavioral Therapy for Insomnia","BBTI","Sleep Quality","Grief","Bereavement","Complicated Grief Reactions","2025-11-14",{"date":362,"type":37},"2025-11-17",{"date":364,"type":21},"2025-12-30",{"date":366,"type":21},"2027-05-31",{"name":368,"class":44},"University of Aarhus",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":380,"conditions":381,"keywords":385,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100537740","early-phase-1-cognitive-behavioral-therapy-and-trazodone-effects-on-sleep-and-blood-pressure-in-insomnia-100537740","NCT06281756","Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia","Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort\u002FRandomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.\n* Meets criteria for chronic insomnia\n* Body Mass Index (BMI) 18.5 kg\u002Fm2 and higher\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.\n* Unwilling to share email address\u002Fcell phone number to accept survey links.\n* Life time diagnosis of psychotic or bipolar disorder\n* History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.\n* Started new or changed treatment for sleep apnea in the past three months\n* Does not meet criteria for chronic insomnia\n* Meets criteria for narcolepsy or hypersomnia disorder\n* Meets criteria for circadian rhythm disorder (including night shift work)\n* Unstable medical conditions that would make participation unsafe or unfeasible\n* Falls resulting in hospitalization, significant injury or fracture within past 12 months\n* 2 hospitalizations or emergency room visits within past 12 months for chronic conditions\n* Active chemotherapy or radiation therapy for cancer\n* Lifetime diagnoses\u002Ftreatment of chronic renal failure, hepatic insufficiency, chronic heart failure\n* Does not agree to refrain from other treatments for insomnia beyond what is offered in this study\n* BMI less than 18.5\n* Substance abuse or dependence in the past 12 months\n* Current use of prescription or over the counter medications taken for sleep greater than 2 times per week\n* Current use of systemic corticosteroids or opiate medications\n* Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study\n* Current use of medications contraindicated with trazodone\n* Sleep apnea or periodic leg movement disorder as determined by sleep study\n* Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg\n* EKG corrected QT interval greater than or equal to 500 ms",{"count":377,"type":21},600,[379],"EARLY_PHASE1","Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.",[29,30,382,383,384],"Insomnia, Primary","Blood Pressure","Blood Pressure, High",[118,386,272],"sleep disorder","2025-11-06",{"date":309,"type":37},{"date":390,"type":37},"2024-03-20",{"date":392,"type":21},"2028-05-31",{"name":394,"class":44},"Milton S. Hershey Medical Center",4,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100592652","effect-of-acupuncture-on-chronic-nonspecific-neck-pain-and-insomnia-100592652","NCT06996210","Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia","Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia","Inclusion Criteria:\n\n1. Aged 18 to 75 years old;\n2. Meet the diagnostic criteria for both chronic nonspecific neck pain and chronic insomnia;\n3. The patient's average 24-hour overall neck pain intensity score on the NRS is ≥3;\n4. The patient's Insomnia Severity Index (ISI) score is ≥10;\n5. The patient is willing to participate in the study and has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Specific neck pain with a clear etiology, including trauma, tumor, connective tissue disease, rheumatic disease, metabolic and endocrine disorders, neuropathy, spinal cord disease, fracture, or vertebral misalignment;\n2. Positive Spurling test, neck flexion test, upper limb traction test, or foraminal distraction test. Neck pain accompanied by radiating pain in the upper limbs or radicular compression symptoms, or acute exacerbation of neck pain;\n3. Neck pain accompanied by sensory disturbances or other neurological symptoms, or ankylosis of the facet joints;\n4. Previous history of cervical spine surgery;\n5. Previous history of head and neck trauma, such as whiplash injury;\n6. Insomnia caused by medications (e.g., caffeine, corticosteroids), withdrawal reactions, or other underlying conditions (e.g., hyperthyroidism, severe anxiety\u002Fdepressive disorders);\n7. Long-term use of analgesics, muscle relaxants, or hormones, or presence of other pain more severe than neck pain;\n8. Other sleep disorders, such as sleep apnea syndrome, or shift workers;\n9. Presence of psychiatric disorders (e.g., depression), cognitive impairment, or language disorders;\n10. Patients with drug dependency;\n11. Received acupuncture treatment within the past month;\n12. Severe cardiovascular, hepatic, renal, hematologic, autoimmune diseases, infectious diseases, poor general nutritional status, malignancy, or patients in the terminal stage of severe illness;\n13. Pregnant or planning to become pregnant within the next year, breastfeeding, or postpartum ≤12 months.","75 Years",{"count":405,"type":21},124,[57],"The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.",[409,30],"Neck Pain Chronic","2025-07-10",{"date":412,"type":37},"2025-07-15",{"date":414,"type":21},"2025-09-01",{"date":416,"type":21},"2028-03-27",{"name":418,"class":44},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":45},"100572690","sleep-treatment-education-program-for-cancer-survivors-step-together-100572690","NCT06736548","Sleep Treatment Education Program for Cancer Survivors: STEP-Together","Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors","Inclusion Criteria:\n\n* Age 18-89\n* History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months prior\n* No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned.\n* Significant insomnia as evidenced by an Insomnia Severity Index score ≥ 8\n* Regular access to the internet\n* Able to read and write in English\n\nExclusion Criteria:\n\n* Usual bedtime does not fall between 5:00 pm and 5:00 am.\n* Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).\n* Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.\n* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.","89 Years",{"count":428,"type":21},100,[57],"This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.",[29,30,432],"Survivorship",[29,434,435],"Chronic Insomnia","Cancer Survivorship","2025-07-01",{"date":438,"type":37},"2025-07-02",{"date":440,"type":37},"2025-06-25",{"date":442,"type":21},"2026-12-31",{"name":444,"class":44},"Dana-Farber Cancer Institute",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":452,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":45},"100590565","memory-training-in-insomnia-with-cognitive-impairment-100590565","NCT06969066","Memory Training in Insomnia With Cognitive Impairment","Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment","Inclusion Criteria:\n\n1. Meets the diagnostic criteria for Insomnia Disorder according to DSM-5.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5.\n3. Age ≥ 8 years.\n4. Voluntary participation with signed informed consent.\n5. Meets the cognitive impairment criteria associated with CI:\n\n(1) Right-handedness. (2) Age between 55 and 75 years. (3) Education duration ≥ 12 years. (4) At least junior high school education level; fulfills Petersen's diagnostic criteria for mild cognitive impairment: 1.Subjective complaints of memory decline. 2.Duration of cognitive complaints ≥ 3 months. 3.Assessment scores: Global Deterioration Scale (GDS) rating of stage 1-2; Clinical Dementia Rating (CDR) score of 0-0.5. 4.Memory test scores falling ≥ 1.5 standard deviations below the age- and education-matched norms: MMSE ≥ 24, MoCA \\\u003C 26, Activities of Daily Living (ADL) score \\> 26. 5.Memory impairment as the primary deficit, with relatively preserved functioning in other cognitive domains.\n\n6.Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.\n\nExclusion Criteria:\n\n1. Presence of severe physical illnesses or major psychiatric disorders, or assessed risk of suicide.\n2. Diagnosed or suspected sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or currently engaged in shift work.\n3. Pregnancy or breastfeeding.\n4. Currently undergoing any form of psychological therapy.\n5. History of infectious diseases such as syphilis or HIV.","8 Years",{"count":454,"type":21},70,[57],"This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.",[458,30,459],"Cognitive Therapy\u002FMethods","Cognitive Dysfunction","2025-05-25",{"date":462,"type":37},"2025-05-28",{"date":464,"type":37},"2024-11-01",{"date":466,"type":21},"2025-11-01",{"name":468,"class":44},"Xuanwu Hospital, Beijing",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":452,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":486,"leadSponsor":487,"locationsCount":45},"100590566","ba-duan-jin-for-ci-with-hyperarousalanxiety-100590566","NCT06969079","Ba Duan Jin for CI With Hyperarousal\u002FAnxiety","Effectiveness of Ba Duan Jin Exercise on Chronic Insomnia (CI) With Hyperarousal\u002FAnxiety","Inclusion Criteria:\n\n1. Diagnosed with Insomnia Disorder according to DSM-5 criteria.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5.\n3. Age ≥ 8 years.\n4. Educational level of at least junior high school.\n5. Voluntarily agree to participate and sign informed consent.\n6. Presence of anxiety symptoms, defined as a Hamilton Anxiety Rating Scale (HAMA-14) score ≥ 14.\n\nExclusion Criteria:\n\n1. Presence of severe physical illnesses or major psychiatric disorders, or assessed to be at risk of suicide.\n2. Diagnosis or suspicion of sleep breathing disorder, restless legs syndrome, circadian rhythm sleep disorder, or engaged in night-shift work.\n3. Pregnancy or breastfeeding.\n4. Currently undergoing any form of psychological therapy.",{"count":477,"type":21},84,[57],"This randomized controlled trial aims to evaluate the effectiveness of Ba Duan Jin exercise in treating chronic insomnia (CI) with comorbid hyperarousal and anxiety symptoms.",[481,30],"Mind-Body Therapies","2025-05-19",{"date":484,"type":37},"2025-05-23",{"date":464,"type":37},{"date":466,"type":21},{"name":468,"class":44},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":45},"100587281","assessment-of-usability-and-preliminary-effectiveness-of-a-digital-sleep-aid-in-an-italian-sample-100587281","NCT06926348","Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample","Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors: A Randomized Clinical Trial","REST","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Diagnosis of chronic insomnia according to DSM-5 criteria\n* Willingness to participate in the study and provide informed consent\n* Personal active email address\n* Ownership of a compatible mobile device with internet access (for the DHT group)\n\nExclusion Criteria:\n\n* Medical conditions requiring hospital admission during the study period\n* Comorbid diagnosis of sleep-related breathing disorders\n* Neurological disorders affecting sleep (e.g., narcolepsy, parasomnias, epilepsy, neurodegenerative diseases)\n* Currently receiving psychological treatment for insomnia or planning to do so within the next 6 months\n* Incompatible smartphone or lack of internet access (for DHT group)","70 Years",{"count":111,"type":21},[57],"Chronic insomnia affects approximately 30% of the Italian population, leading to significant impairments in daily functioning and overall health. While Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, access is limited due to a shortage of trained specialists and resources within the Italian healthcare system. This study aims to evaluate the usability, acceptability, and preliminary effectiveness of a mobile application designed to assist individuals with chronic insomnia. The app offers digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot to promote healthy sleep behaviors. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either the intervention group, which will use the mobile application alongside their usual treatment, or to a control group receiving only standard care. The primary outcomes will assess the app's usability and participants' adherence to sleep hygiene practices. Secondary outcomes will evaluate changes in insomnia severity, mood, and quality of life. Assessments will occur at the start of the study, after the 8-week intervention, and at a 6-month follow-up to explore the intervention's long-term effects.",[30,29],[29,502,503,504,505],"CBT-i","Cognitive Behavioral Therapy for Insomnia","Digital Health Technology","DTx","2025-04-13",{"date":508,"type":37},"2025-04-17",{"date":510,"type":37},"2025-03-10",{"date":512,"type":21},"2026-03-10",{"name":514,"class":44},"Universita di Verona",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":452,"maxAge":521,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":45},"100547632","digital-dyadic-family-based-intervention-to-improve-sleep-in-children-with-odd-and-their-parents-nitecapp-sincc-pilot-100547632","NCT06410495","Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)","Inclusion criteria:\n\n1. Child ages 8-17 with ODD (prior diagnosis) and insomnia\n2. Child and parent English proficiency.\n\nInsomnia:\n\n1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos\n2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia\n3. baseline diaries and actigraphy indicate \\>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights\n\nExclusion criteria:\n\n1. Parent unable to provide informed consent or child unable to provide assent\n2. Family unwilling to accept random assignment\n3. Child\u002Fparent participation in another randomized research project\n4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment\n5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation\u002Fintent, \\[frequent\\] parasomnias)\n6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and\u002For melatonin\n7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)\n9. Other conditions adversely affecting trial participation","17 Years",{"count":20,"type":21},[57],"In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.",[526,30],"Oppositional Defiant Disorder","2025-03-24",{"date":529,"type":37},"2025-03-28",{"date":531,"type":37},"2024-05-01",{"date":533,"type":21},"2025-12-01",{"name":74,"class":44},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":452,"maxAge":542,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":45},"100543009","sleep-cope-sleep-intervention-for-oppositional-children-100543009","NCT06350292","SLEEP-COPE: Sleep Intervention for Oppositional Children","SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions","Inclusion criteria:\n\n1. Child ages 8-12 with ODD (prior diagnosis) and insomnia\n2. Child and parent English proficiency.\n\nInsomnia:\n\n1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos\n2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia\n3. baseline diaries and actigraphy indicate \\>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights\n\nExclusion criteria:\n\n1. Parent unable to provide informed consent or child unable to provide assent\n2. Family unwilling to accept random assignment\n3. Child\u002Fparent participation in another randomized research project\n4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment\n5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation\u002Fintent, \\[frequent\\] parasomnias)\n6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and\u002For melatonin\n7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)\n9. Other conditions adversely affecting trial participation","12 Years",{"count":7,"type":21},[57],"Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.",[30,526],{"date":529,"type":37},{"date":549,"type":37},"2024-04-01",{"date":551,"type":21},"2025-10-01",{"name":74,"class":44},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":403,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":568,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":580,"leadSponsor":581,"locationsCount":45},"100543128","sleep-well-despite-persistent-pain-symptoms-100543128","NCT06351839","Sleep Well Despite Persistent Pain Symptoms","Metacognitive Behavioral Therapy Integrated in Sleep Treatment for Comorbid Insomnia in Patients With Persistent Pain: A Randomized Controlled Semi-Crossover Clinical Trial","Sleep-Well","Inclusion Criteria:\n\n* Patients who, after clinical examination at University hospital of Northern Norway (UNN) fill the criteria for a chronic non-malignant pain diagnosis according to ICD-10.\n* Satisfy criteria for a comorbid insomnia\n* Both first-time referrals and former referred patients.\n\nExclusion Criteria:\n\n* A comorbid drug abuse diagnosis (ICD-10)\n* An ongoing compensation and\u002For insurance case related to a health issue, illness or treatment\n* Drug treatment using \\>100 morphine equivalents\n* Participation in other group-based treatments at the UNN Pain Department or the Physical Outpatient Medical Clinic (must be completed before inclusion)",{"count":562,"type":21},106,[57],"Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The \"Sleep-Well\" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality.\n\nEligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.\n\nAims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.\n\nThe intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later.",[30,566,567],"Insomnia Due to Medical Condition","Pain, Chronic",[29,569,570,571,572,573,574,575],"Comorbid insomnia","Chronic pain","MetaCognitive Therapy for Insomnia","Sleep Hygiene","Sleep Education","Sleep Restriction","Group therapy","2025-02-21",{"date":578,"type":37},"2025-02-24",{"date":179,"type":37},{"date":311,"type":21},{"name":582,"class":44},"University of Tromso",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":591,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":601,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":608,"leadSponsor":610,"locationsCount":612},"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","80 Years",{"count":593,"type":21},160,[57],"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.",[597,598,29,30,382,599,600],"Insomnia Disorders","Insomnia Disorder","Insomnia, Nonorganic","Insomnia Type; Sleep Disorder",[272,269,602,603],"bedtime restriction","sleep restriction","2025-02-13",{"date":606,"type":37},"2025-02-17",{"date":510,"type":21},{"date":609,"type":21},"2027-11-01",{"name":611,"class":44},"Christoph Nissen",2,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":620,"maxAge":403,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":45},"100562518","improvement-of-sleep-quality-of-insomnia-patients-with-binaural-beats-100562518","NCT06604208","Improvement of Sleep Quality of Insomnia Patients with \"Binaural Beats\"","Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with \"Binaural Beats\"","Inclusion Criteria:\n\n* Gender: No restrictions, Age: Between 20 and 75 years.\n* Meets the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):\n\n  1. Difficulty sleeping and insomnia occurring at least 3 nights per week.\n  2. Insomnia and sleep difficulties persisting for at least 3 months.\n* The participant has signed the informed consent form.\n\nExclusion Criteria:\n\n* Individuals who are unable to complete the consent form, undergo testing, and attend regular follow-up visits as required by the study.\n* Individuals with severe physical illnesses or post-surgical conditions, such as heart disease or metabolic disorders.\n* Individuals with severe psychiatric disorders, including schizophrenia, major depressive disorder, severe anxiety disorder, bipolar disorder, dementia, or substance use disorders; or severe neurological conditions, such as stroke or epilepsy.\n* Individuals with other severe sleep disorders, such as severe sleep apnea.\n* Individuals who are unable to maintain a stable medication dosage during the trial period, particularly with ongoing treatments.\n* Patients deemed unsuitable for participation in the trial by the principal investigator.\n* Patients who are unable to adhere to sleep hygiene practices or who cannot refrain from using electronic devices before bedtime.","20 Years",{"count":622,"type":21},74,[57],"The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are:\n\nWhat medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a placebo to see if binaural beat works to treat chronic insomnia.\n\nParticipants will:\n\nUsing binaural beat or a placebo every day for 2 weeks Keep a diary and actigraphy of their insomnia symptoms Visit the clinic after 2 weeks testing for checkups and tests",[30],"2025-02-12",{"date":628,"type":37},"2025-02-14",{"date":630,"type":37},"2024-12-27",{"date":632,"type":21},"2025-08-31",{"name":634,"class":44},"Chang Gung Memorial Hospital",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":452,"maxAge":403,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":643,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":653,"locationsCount":45},"100577360","the-impact-of-light-electrical-and-magnetic-neuroregulation-interventions-on-sleep-wake-disorders-100577360","NCT06797284","The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders","Inclusion Criteria:\n\n\\- Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with major neurological diseases such as multi-infarct dementia, Huntington\\'s disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.\n2. A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).\n3. History of severe drug or alcohol abuse within the past year;\n4. Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.\n5. Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.",{"count":642,"type":21},20,[57],"Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical\u002Fmagnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .",[30,646,647],"Narcolepsy","REM Sleep Behavior Disorder","2025-02-11",{"date":628,"type":37},{"date":651,"type":37},"2025-02-01",{"date":442,"type":21},{"name":654,"class":44},"Second Affiliated Hospital of Soochow University"]