[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insomnia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insomnia":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,214,0,25,[9,56,79,105,129,153,180,205,230,260,284,305,331,358,384,409,432,456,484,515,539,559,586,606,629],{"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":25,"conditions":26,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[27,28,29,30,31,32,33,34,35,36],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[27,28,38,29,39,35,40,41,42],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":47},"2024-05-10",{"date":51,"type":21},"2027-06",{"name":53,"class":54},"Johns Hopkins University","OTHER",5,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100054267","efficacy-of-digital-cognitive-behavioral-therapy-for-insomnia-cbt-i-utilizing-embodied-artificial-intelligence-agent-in-virtual-reality-100054267","NCT07699042","Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality","Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults of Chinese ethnicity, aged between 18 and 65 years.\n* Presence of insomnia, as indicated by a score of 10 or higher on the ISI.\n* Meeting the DSM-IV-TR diagnostic criteria for insomnia disorder. The 1-month duration criterion in DSM-IV-TR rather than the 3-month criterion in DSM-V is adopted to broaden the clinical relevance of the study findings.\n* Willing to provide online informed consent to participate in the study.\n* Willing to comply with the requirements outlined in the study protocol.\n* Possession of a smartphone and consistent internet access for smartphone use.\n* Acceptance of the terms of service and privacy policies of the mobile apps used for intervention delivery.\n\nExclusion Criteria:\n\n* A current or history of any sleep disorders other than insomnia disorder, such as narcolepsy, obstructive sleep apnea, and restless legs syndrome.\n* A current or history of mental retardation or neuropsychiatric disorders other than depression or anxiety or stress disorders (as they are considered treatment outcomes), including bipolar disorder, schizophrenia, and substance use disorder.\n* Presence of serious suicidality, demonstrated by ideation with a plan or a previous suicide attempt.\n* Currently receiving long-term pharmacological treatment, including sleep-promoting agents.\n* Currently undergoing structured psychotherapy.\n* A current or history of significant visual, auditory, or balance impairment.\n* A current or history of epilepsy\n* Subject who is preparing for pregnancy or pregnant\n* A current or history of any voice, speech, language disorders and learning difficulties.\n* A current or history of severe health conditions (e.g., stroke, heart attack)\n* Engaged in shiftwork or trans-meridian travel within the past 3 months or during the study.","65 Years",{"count":65,"type":21},168,[24],"The goal of this clinical trial is to evaluate whether a virtually embodied artificial intelligence (AI) agent delivered via VR-enhanced digital cognitive behavioral therapy for insomnia (dCBT-I) can improve insomnia outcomes and treatment adherence in adults with insomnia.\n\nThe main questions it aims to answer are:\n\n\\- Does VR-enhanced dCBT-I with an embodied AI agent lead to greater improvements in insomnia symptoms compared to app-based dCBT-I with an AI chatbot at post-intervention and 3-month follow-up?\n\nResearchers will compare VR-enhanced dCBT-I with an embodied AI agent to app-based dCBT-I with an AI chatbot to see if the VR-enhanced intervention results in significantly improved clinical outcomes and adherence.\n\nParticipants will:\n\n* Be randomly assigned to either the VR-enhanced AI agent intervention group or the app-based AI chatbot control group\n* Complete a digital cognitive behavioral therapy for insomnia (dCBT-I) program with either a virtually embodied AI agent (VR-based) or a chatbot-based application\n* Undergo assessments at baseline, post-intervention, and 3-month follow-up",[28],"NOT_YET_RECRUITING","2026-07-08",{"date":46,"type":47},{"date":73,"type":21},"2026-10-23",{"date":75,"type":21},"2029-04-22",{"name":77,"class":54},"Chinese University of Hong Kong",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":78},"100053547","clinical-trial-for-acupuncture-in-adolescents-with-psychological-distress-and-insomnia-100053547","NCT06638450","Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia","Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Psychological Distress: a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes","Inclusion Criteria:\n\nParticipants will be eligible for this study if they:\n\n1. are experiencing anxiety as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63), and\u002For a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63);\n2. have symptoms that have persistent for more than 3 months;\n3. are able to provide informed consent for participation, and complete treatments and questionnaires as scheduled; and\n4. have no suicidal ideation, as evidenced by \"no\" answers or a score of \\\u003C3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS).\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n1. have unstable systemic medical conditions that may limit their participation in the study, for example, severe liver, cardiovascular, or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease; acute infectious disease; or any conditions with unstable vital signs or require intensive hospitalization;\n2. have bipolar or psychotic disorder (e.g. schizophrenia);\n3. have a history of brain injury or surgery;\n4. have alcohol abuse or substance abuse;\n5. are pregnant or in lactation, or intend to conceive;\n6. have heart pacemaker or other metal devices implanted in the body;\n7. have concurrent or use of drug treatment for anxiety\u002Fdepression in the previous 6 months;\n8. have treatment with acupuncture or brain stimulation in the previous 6 months;\n9. have a history of epilepsy;\n10. have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment; or\n11. involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.","15 Years","22 Years",{"count":89,"type":21},148,[24],"This is an assessor-blinded, randomized, MAS-controlled trial. A total of 148 adolescents aged 15-22 years experiencing mild to moderate anxiety or depressive symptoms will be recruited. They will be randomly assigned to DCEAS+BA (n = 74) and MAS (n = 74) for 2 sessions per week for 8 weeks, followed by a 4-week post-treatment observation period. A post-intervention visit will be held at week 12. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS) as additional assessments for anxiety and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Assessment will be carried out every 4 weeks till week 12, while saliva will be collected at baseline and at the end of the 8 weeks. Salivary oxytocin and cortisol will be analyzed. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine intercorrelations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.",[93,28],"Psychological Distress",[95,28,96,97],"Psychological distress","Acupuncture","Adolescent",{"date":46,"type":47},{"date":100,"type":21},"2026-07",{"date":102,"type":21},"2028-09",{"name":104,"class":54},"The University of Hong Kong",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100645046","digital-insomnia-and-circadian-therapy-for-reducing-depression-symptoms-in-college-students-100645046","NCT07677930","Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students","Prevent Worsening of Depressive Symptoms Using Digital Cognitive Behavioral Therapy for Insomnia and Circadian Intervention in College Students","Inclusion Criteria:\n\n* Youths aged between 18-24 years old.\n* Insomnia disorders as determined by DSM-5 criteria with a predominant complaint of difficulty initiating sleep.\n* Presence of an evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a late bedtime of 12:00 am\u002Fmidnight or later for at least 3 nights per week in the last 3 months.\n* Presented with at least subclinical depressive symptoms as determined by Patient Health Questionnaire-9 ≥ 10.\n* Accessibility to a smartphone.\n\nExclusion Criteria:\n\n* Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality other than insomnia and delayed sleep phase syndrome, as ascertained by Structured Diagnostic Interview for Sleep patterns and Disorders (DISP), such as restless leg syndrome and OSA, and narcolepsy.\n* Diagnosed with neuropsychiatric disorders such as major depressive disorder, anxiety disorders, bipolar affective disorders, schizophrenia, moderate or above suicidality.\n* Concurrent, regular use of medications known to affect sleep continuity and quality, including both Western medications (e.g. hypnotics, steroids, antidepressants, antihistamines) and over-the-counter medications (e.g. melatonin).\n* Participate in other psychotherapy (e.g., CBT, mindfulness) currently or in the past three months.","24 Years",{"count":114,"type":21},195,[24],"Depression is a leading cause of global disease burden, poor quality of life, disability and suicide, and commonly occurs in adolescence and early adulthood. Insomnia and circadian factors were regarded as potential targets for preventing worsening of depressive symptoms. Additionally, digital insomnia treatment reduces depressive symptoms but is insufficient for individuals with an evening chronotype. Circadian intervention is an adjunctive treatment for sleep disturbance and depression, but is often overlooked. In this study, we aim to evaluate the effect of guided digital insomnia and circadian intervention (dCBT-I + dCI) in reducing depressive symptoms in college students with insomnia and an evening chronotype compared with digital insomnia intervention alone (dCBT-I) and a health education group (dHE). We also aim to develop and evaluate multimodal prediction models to identify individuals who are more or less likely to respond to the interventions, using clinical, behavioral, circadian, and digital engagement data.",[118,28,119,120],"Eveningness","Circadian Rhythm","Depressed Mood",[118,28,120,119],"2026-06-29",{"date":124,"type":47},"2026-07-01",{"date":124,"type":21},{"date":127,"type":21},"2029-06-30",{"name":77,"class":54},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":78},"100635490","auditory-stimulation-for-insomnia-and-depression-100635490","NCT07553364","Auditory Stimulation for Insomnia and Depression","Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression","Inclusion Criteria:\n\n* Ability to complete overnight EEG study including placement of EEG leads\n* Ability to read and understand English\n* Presence of Insomnia\n* Moderate Depression\n* Home internet and smartphone (Android or Apple) device access\n\nExclusion Criteria:\n\n* Presence of severe, untreated sleep apnea\n* Presence of restless leg syndrome\n* Significant neurological disease (e.g. Parkinson's disease, epilepsy)\n* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation\n* Has active implanted device ( e.g. intracranial device, cochlear implant)\n* Currently deaf or experiencing hearing loss or using hearing aids\n* Currently taking medications that could alter EEG\n* Currently pregnant","20 Years","50 Years",{"count":7,"type":21},[24],"The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following:\n\nDetermine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression.\n\nThe study team hypothesizes that active auditory stimulation will reduce objective and subjective sleep onset latency (SL) and wake after sleep onset (WASO) compared to a sham stimulation.\n\nParticipants will:\n\n* Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active\u002Fsham stimulation, 1 week washout, and 1 week opposite condition - active\u002Fsham stimulation)\n* Wear actigraphy watch for duration of the study\n* Complete questionnaires regarding their sleep, mood, and satisfaction with the device",[142,28],"Depression - Major Depressive Disorder",[144,29,28],"sleep","2026-06-24",{"date":147,"type":47},"2026-06-26",{"date":100,"type":21},{"date":150,"type":21},"2027-12-01",{"name":152,"class":54},"Wake Forest University Health Sciences",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":78},"100590813","phase-1-mindfulness-meditation-for-insomnia-100590813","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.",{"count":161,"type":21},30,[163,164],"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.",[167,28,168,169,170],"Sleep Initiation and Maintenance Disorders","Insomnia Chronic","Mindfulness","Telemedicine","2026-06-21",{"date":173,"type":47},"2026-06-23",{"date":175,"type":47},"2026-03-31",{"date":177,"type":21},"2028-12-29",{"name":179,"class":54},"Brigham and Women's Hospital",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":17,"minAge":18,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":78},"100524487","a-stepped-care-model-to-deliver-cbt-i-in-community-100524487","NCT06109363","A Stepped Care Model to Deliver CBT-I in Community","Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial","Inclusion Criteria:\n\n1. Chinese adults aged 18-70 years old,\n2. The score of Insomnia Severity Index ≥ 10.\n\nExclusion Criteria:\n\n1. present with psychotic disorders such as bipolar disorder and schizophrenia,\n2. present with severe depression or suicidal ideation,\n3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).\n4. unable to provide consent",true,"70 Years",{"count":190,"type":21},1100,[24],"Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress.\n\nThus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.",[28,194],"Sleep Disturbance",[28,196,197],"Stepped care model","Stepped wedge cluster randomized trial","2026-06-19",{"date":145,"type":47},{"date":201,"type":47},"2023-10-23",{"date":203,"type":21},"2027-04-22",{"name":77,"class":54},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":213,"maxAge":63,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100568272","phase-2-suvorexant-for-treatment-of-aud-and-ptsd-100568272","NCT06679062","Suvorexant for Treatment of AUD and PTSD","A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)","SUV","Inclusion Criteria:\n\n* Age between 21 and 65.\n* Meet current (i.e., past 12-month at Day -7\u002F-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.\n* Currently experiencing PTSD symptoms at screening (Day -7\u002F-6) as indicated by PCL-5 cut-score \\> 30.\n* Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.\n* Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.\n* Agree to abstain from all other sleep medications (starting at Day -7).\n* Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s\u002Fhe will lose his\u002Fher housing in the next month.\n\nExclusion Criteria:\n\n* A current (past 12-month at Day -7\u002F-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\\u003C moderate level on DSM 5).\n* A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.\n* Positive urine test for any recreational drugs other than marijuana at screening (Day -7\u002F-6).\n* Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).\n* Currently pregnant, nursing, or no reliable method of birth control (females only).\n* Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).\n* Use of suvorexant (within 30 days of Day -7).\n* Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))\n* Hepatic insufficiency (AST\u002FALT \\> 5x upper limit of normal (ULN)).\n* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.\n* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.","21 Years",{"count":215,"type":21},76,[164],"This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.",[219,220,28],"Alcohol Use Disorder (AUD)","Post Traumatic Stress Disorder (PTSD)","2026-06-18",{"date":173,"type":47},{"date":224,"type":47},"2025-07-16",{"date":226,"type":21},"2027-03",{"name":228,"class":54},"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance",2,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":245,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":78},"100614420","deaf-cbt-ts-to-reduce-suicide-risk-100614420","NCT07279363","Deaf CBT-TS to Reduce Suicide Risk","Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals","Inclusion criteria:\n\n* adult (aged 18 years or older)\n* Self-identify as Deaf or hard of hearing (any degree of hearing loss)\n* Primary method of communication is American Sign Language\n* Positive screen for one or more mental health disorders including depression (PHQ-9 \\> 10), anxiety (GAD-7 \\> 10), posttraumatic stress disorder (PCL-5 \\> 31), insomnia (ISI \\> 15), or alcohol use disorder (AUDIT \\> 16)\n* No current professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services) per standardized self-report\n* Access to video chat technology with internet and webcam.\n\nExclusion criteria:\n\n* unable to communicate with the researcher in American Sign Language\n* current alcohol withdrawal necessitating medical evaluation\n* current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)\n* unable to comprehend the nature of the study",{"count":238,"type":21},110,[24],"The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are:\n\n* Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors?\n* Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use?\n* Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress?\n* Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors.\n\nParticipants will:\n\n* Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment.\n* Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months\n* Complete two follow-up assessments in 2 and 4 months.",[142,242,243,28,219,244],"Anxiety","PTSD - Post Traumatic Stress Disorder","Suicide Ideation",[246,247,248,249,250],"Deaf","Mental Health","Treatment-Seeking","Suicide","Cognitive Behavioral Therapy for Treatment-Seeking","2026-06-17",{"date":253,"type":47},"2026-06-22",{"date":255,"type":21},"2026-09",{"date":257,"type":21},"2029-05",{"name":259,"class":54},"University of Rochester",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100626446","parent-mediated-telehealth-intervention-for-insomnia-in-young-autistic-children-100626446","NCT07435740","Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children","Inclusion Criteria:\n\n* Age \\>3 to 7 years 11 months\n* Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)\n* Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (a score of 4 or more)\n* Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the randomized trial)\n* Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English\n\nExclusion Criteria:\n\n* Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation)\n* Children with a psychiatric disorder or serious behavioral problem requiring a different treatment\n* Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)\n* Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only available in English","3 Years","7 Years",{"count":269,"type":21},130,[24],"This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be randomly assigned to either the SPT or SPE intervention for 10 weeks.",[28],[274],"autism","2026-06-16",{"date":221,"type":47},{"date":278,"type":47},"2026-06-05",{"date":280,"type":21},"2031-01",{"name":282,"class":54},"Emory University",3,{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":137,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":78},"100607635","transcutaneous-auricular-vagus-nerve-stimulation-for-insomnia-in-survivors-of-childhood-acute-lymphoblastic-leukemia-100607635","NCT07191119","Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia","Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Survivor of Acute Lymphoblastic Leukemia (ALL)\n* Enrolled on SJLIFE\n* Participant was less than 21 years of age at time of diagnosis.\n* Age 20-50 years at the time of enrollment\n* Insomnia Severity Index \\>=8 (Proxy \\>=8) confirmed prior to enrollment\n* Access to home Wi-Fi and Smartphone\n* Participant is able to speak and understand the English language\n* Participant is able and willing to give consent\n\nExclusion Criteria:\n\n* Unable to understand the details and requirements of the study (at the discretion of the PI)\n* Female participants who are pregnant or planning to become pregnant\n* Presence of implanted electrical medical devices (i.e. pacemaker)\n* Currently taking medication intended to treat neurocognitive impairment (i.e. stimulants) or medications prescribed for seizure management\n* History of skin irritation or other issues during stimulation of inner ear\n* Currently utilizing a technological intervention for a sleep disorder (e.g. CPAP)\n* Medications and behavioral practices (white noise, night-time yoga, etc) are acceptable as long as the insomnia is persistent.\n* History of a contraindicated health condition including:\n* Syncope (CTCAE \\>2)\n* Cardiac dysrhythmia (CTCAE \\>2)\n* Vascular Disease (CTCAE \\>2)\n* Coronary Artery Disease (CTCAE \\>2)\n* Active contraindicated heath condition including:\n* Cranial Nerve Disorder (CTCAE \\>2)\n* Neuropathy (Cranial Nerves) (CTCAE \\>2)\n* Neuralgia (Cranial Nerves) (CTCAE \\>2)\n* Overt Cerebrovascular Accident (CTCAE \\>2)\n* Seizures (Any in most recent 1 year\n* Currently enrolled or participating in any other neurostimulation or neuromodulation ancillary research studies",{"count":292,"type":21},40,[24],"This pilot study will assess the usefulness and potential effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) for treating insomnia in adult survivors of childhood acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either active (verum) or inactive (sham) nightly stimulation using a non-invasive earbud device over two time periods: 2 weeks and 8 weeks. The study will assess adherence to the intervention and estimate its effects on sleep quality, stress, and neurocognitive function.\n\nPrimary Objective:\n\nAim 1: To determine a) short-term and b) long-term feasibility of tVNS in terms of participation in ALL Survivors with moderate to severe insomnia.\n\nAim 2: To estimate the effect size of tVNS on sleep quality, stress, and neurocognitive outcomes in ALL survivors with insomnia.\n\nExploratory Objectives\n\nAim 1: To investigate the onset of tVNS effect via actigraphy measures over the intervention epoch.\n\nAim 2: To estimate the effect size of genetic variants on sleep quality within verum tVNS.",[296,28,297],"Survivor of Childhood Cancer","Acute Lymphoblastic Leukemia (ALL)","2026-06-15",{"date":251,"type":47},{"date":175,"type":47},{"date":302,"type":21},"2029-12",{"name":304,"class":54},"St. Jude Children's Research Hospital",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":312,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":78},"100599950","digital-cognitive-behavioral-treatment-of-insomnia-in-youth-an-rct-examining-feasibility-acceptability-and-efficacy-of-nitecapp-jr-100599950","NCT07091149","Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr","NiteCAPP JR","Inclusion Criteria:\n\nChild inclusion:\n\n1. 6-12 yrs\n2. Verbal IQ \\> 70 (to ensure verbal skills are sufficient to participate in treatment)\n3. participation of child's parent or legal guardian living in the same home\n4. child diagnosed with insomnia, 5) willing to accept random assignment.\n\nInsomnia:\n\n1\\) insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying asleep, and\u002For waking up too early, (b) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, and (c) Pediatric Insomnia Severity Index score \\>8\n\nCaregiver inclusion:\n\n1. ability to read and understand English at the 5th grade level\n2. willing to accept random assignment.\n\nExclusion Criteria:\n\nChild exclusion:\n\n1. child unable to provide informed consent or child unable to provide assent\n2. child unwilling to accept random assignment\n3. child participation in another randomized research project\n4. child 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 as described in #7 (see Notes below for details)\n7. child stimulants, sleep medications (prescribed or OTC), and\u002For melatonin within the last 1 month (unless stabilized on medication for 3+ months)\n8. child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n9. child other conditions adversely affecting trial participation.\n\nCaregiver exclusion criteria:\n\n1. unable to provide informed consent\n2. unwilling to accept random assignment\n3. caregiver participation in another randomized research project\n4. unable to complete forms or implement treatment procedures due to cognitive impairment\n5. caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial","6 Years","12 Years",{"count":292,"type":21},[24],"The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.",[28],[319,320,321,322],"dCBTi","digital intervention","insomnia","children","2026-06-11",{"date":298,"type":47},{"date":326,"type":47},"2025-04-10",{"date":328,"type":21},"2027-05-01",{"name":330,"class":54},"University of South Florida",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":346,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":78},"100491071","training-in-evidence-based-treatments-in-psycho-oncology-100491071","NCT05674357","Training in Evidence-based Treatments in Psycho-Oncology","Patient Inclusion Criteria:\n\n* Adults \\> 18 years of age.\n* Currently receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance.\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3.\n* Reports distress or presenting problem is related to patients' illness and\u002For treatment (e.g., cancer treatment).\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.\n* Located in the state of Massachusetts for the duration of sessions.\n\nCaregiver Inclusion criteria:\n\n* Adults \\> 18 years of age\n* Currently caring for someone receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3\n* Reports distress or presenting problem is related to caregiving\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for caregiving-related distress per therapist and supervising therapist discretion\n* Located in the state of Massachusetts for the duration of sessions\n\nPatient Exclusion Criteria:\n\n* Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n* Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).\n* Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.\n* Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n\nTherapist Inclusion criteria:\n\n-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.\n\nTherapist Exclusion criteria:\n\n-Obtained licensure as a clinical psychologist in any state.",{"count":338,"type":21},115,[24],"The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress.\n\nThe intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.\n\n* Cognitive Behavioral Therapy (CBT)\n* Acceptance Commitment Therapy (ACT)\n* Mindfulness-Based Cognitive Therapy (MBCT)\n* Mindfulness-Based Stress Reduction (MBSR)\n* Meaning-Centered Psychotherapy (MCP)\n* Cognitive Behavioral Therapy for Insomnia (CBT-I)\n* CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.\n\nParticipation in this research study is expected to last about 26 weeks.\n\nIt is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.",[342,343,344,345,28],"Distress, Emotional","Depression, Anxiety","Fatigue","Pain",[347,348,349,242,29,350],"CBT","Cognitive-Behavioral Therapies","Emotional Distress","Symptom-Related Distress",{"date":298,"type":47},{"date":353,"type":47},"2023-01-09",{"date":355,"type":21},"2029-01-01",{"name":357,"class":54},"Massachusetts General Hospital",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":78},"100622500","phase-4-effects-of-lemborexant-on-motor-sleep-comorbidity-in-parkinsons-disease-100622500","NCT07384429","Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease","Study for the Dual Orexin Receptor Antagonist Lemborexant in Improving Motor-Sleep Comorbidity in Parkinson's Disease","Inclusion Criteria:\n\n* 1\\. Aged 50 years or older;\n* 2\\. Diagnosed with idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (2015), with a Hoehn \\& Yahr stage of 1 to 4;\n* 3\\. Disease duration of ≥ 2 years since diagnosis, clinically stable, and able to comply with the research assessments and interventions;\n* 4\\. Diagnosis of insomnia disorder meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with an Insomnia Severity Index (ISI) score of ≥ 15;\n* 5\\. Stable medication regimen for at least 4 weeks prior to the study;\n* 6\\. Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study.\n\nExclusion Criteria:\n\n* 1\\. History of or diagnosis with a severe psychiatric disorder, such as depression, anxiety disorders, schizophrenia spectrum disorders, or bipolar disorder;\n* 2\\. Presence of a clinically defined neurological disorder (assessed via self-report), including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, history of stroke, transient ischemic attack within the past 2 years, cerebral aneurysm, dementia, or multiple sclerosis;\n* 3\\. Severe cognitive impairment (Mini-Mental State Examination (MMSE) score below 24) or inability to complete questionnaires independently;\n* 4\\. Chronic obstructive pulmonary disease (COPD) or any lifelong history of sleep-related breathing disorders, such as sleep apnea;\n* 5\\. Excessive daytime sleepiness, defined as self-reported daily daytime napping ≥ 1 hour per day on ≥ 3 days per week;\n* 6\\. Regular caffeine consumption;\n* 7\\. Use of any orexin receptor related medication within the past 3 months.\n* 8\\. Previous history of cataplexy or known reduced orexin levels;\n* 9\\. Inability to read or understand Chinese;\n* 10\\. Use of other sleep-promoting medications within the past 3 months.",{"count":366,"type":21},44,[368],"PHASE4","The aim of this study is to explore the effects of the dual orexin receptor antagonist Lemborexant on improving motor and sleep comorbidity in patients with Parkinson's disease. This study will provide clinical evidence for the application of dual orexin receptor antagonists in the treatment of Parkinson's Disease.",[371,28,372],"Parkinson's Disease","Motor Disorder",[371,374,375,28,372],"Lemborexant","orexin receptor antagonist","2026-06-09",{"date":323,"type":47},{"date":379,"type":21},"2026-08-19",{"date":381,"type":21},"2026-12-01",{"name":383,"class":54},"YangPan",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":392,"targetDuration":4,"studyType":22,"phases":394,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":78},"100548977","phase-2-efficacy-of-cognitive-behavioral-therapy-for-insomnia-to-treat-insomnia-symptoms-in-individuals-with-multiple-sclerosis-100548977","NCT06428006","Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis","Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis","CALM","Inclusion Criteria:\n\n* 18-65 years old\n* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist\n* Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)\n* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights\u002Fweek for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5\n* ≥10 on Insomnia Severity Index\n* English speaking\n* ≥31 on modified Telephone Interview of Cognitive Status23\n* Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study\n* Report having access to internet service or a data plan and access to a computer, tablet, or smart phone\n\nExclusion Criteria:\n\n* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)\n* \\>3 on STOP BANG indicating increased risk of sleep apnea\n* Restless legs syndrome as determined by RLS-Diagnosis Index\n* Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised\n* Parasomnia as determined by the Sleep Disorders-Revised\n* Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia\n* Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)\n* Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety\n* Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria\n* History of other nervous system disorder such as stroke or Parkinson's disease\n* Currently pregnant or intending to become pregnant in the next 6 months\n* Severe mental illness such as schizophrenia or bipolar disorder\n* Severe neurological or sensory impairments that would interfere significantly with testing\n* Relapse and\u002For corticosteroid use in the past 8 weeks\n* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am\n* Currently receiving a behavioral sleep health intervention",{"count":393,"type":21},70,[164],"The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).",[397,28],"Multiple Sclerosis",[399,400],"Cognitive behavioral therapy for insomnia","CBT-I",{"date":402,"type":47},"2026-06-12",{"date":404,"type":47},"2024-07-30",{"date":406,"type":21},"2027-05-31",{"name":408,"class":54},"University of Kansas Medical Center",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100642487","post-concussion-sleep-and-brain-heart-functions-100642487","NCT07636408","Post-Concussion Sleep and Brain-heart Functions","Enhancing Sleep to Improve Brain-heart Functions in People With Persistent Post-concussion Symptoms","CBT-pI","Inclusion Criteria:\n\n1. Adults 18 years and older\n2. Experiencing persisting post-concussion symptoms \\> 4 weeks but no more than 12 months post-injury as measured based on home-made screening questions and the Sport Concussion Assessment Tool (SCAT6)\n3. Having a Sleep Condition Indicator score suggestive of insomnia (SCI =\u002F\\\u003C 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month)\n4. Meeting diagnostic criteria for insomnia disorder on the SCID\n5. Having a smartphone, tablet or computer and willingness to install a sleep intervention application on it\n\nExclusion Criteria:\n\n1. Having undergone another CBT-I program within the past 6 months\n2. Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I.\n3. Self-reported substance use disorder (i.e., alcohol, cannabis, or illicit drugs) or =\u002F\\> monthly use of illicit drugs reported on item-2 of the WHO-ASSIST (except tobacco, alcohol, and cannabis)\n4. Body mass index \\> 45\n5. Shift work or rotating shifts within 1 month of study entry\n6. Recent travel to a different time zone (leaving 1 week of recovery per time zone difference)\n7. Any clinically significant neurological disorder aside from concussion (including seizure disorder)\n8. Signs of sleep apnea as reflected by combined profiles on the Sleep Disorders Symptoms Checklist-25 and Epworth Sleepiness Scale\n9. Unstable psychotropic medications (need to be on a stable dose for at least 1 month prior to study start)\n10. Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires",{"count":393,"type":21},[24],"This project is designed as a randomized controlled trial (RCT), with an active control group. Sleep and heart rate will be monitored at home for 1 week before and after the intervention. Questionnaires will be completed from home before, during and 8 weeks after the end of the Intervention. The Cognitive Behavioural Therapy for Insomnia, adapted for post-concussed individuals (CBT-pI) and control interventions, will be delivered on a digital online platform over an 8-week period. Participants in the control arm will be offered CBT-pI after the follow-up period. All intervention arms will be delivered as adjuncts to standard clinical care. All other treatments received during the intervention will be documented.",[28,421],"Concussion Post Syndrome",[41,423],"digital therapy","2026-06-08",{"date":323,"type":47},{"date":427,"type":21},"2026-06",{"date":429,"type":21},"2027-04",{"name":431,"class":54},"University of Ottawa",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":454,"locationsCount":78},"100643180","a-theory-based-sleep-hygiene-education-for-insomnia-disorder-100643180","NCT07642479","A Theory-based Sleep Hygiene Education for Insomnia Disorder","A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis","Inclusion Criteria:\n\n* Hong Kong residents\n* Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua\n* Who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire\n* Scored at least 10 points in the Insomnia Severity Index\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV\n* Other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)\u002Fperiodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS\u002FPLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment\n* Any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia\n* Taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders\n* Impaired cognitive functioning (\\\u003C22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions\n* Pregnant\n* Shift work",{"count":440,"type":21},264,[24],"Insomnia is a prevalent sleep disorder associated with numerous adverse health outcomes, including fatigue, irritability, and impaired daytime functioning. Despite the availability of effective pharmacological and psychological treatments, relatively few individuals with insomnia seek professional help, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. Building on our previously registered pilot-testing protocol, this study aims to examine the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community population. Furthermore, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as cognitive behavioral therapy for insomnia (CBT-I) delivered via digital applications. Therefore, this study will also compare the effectiveness of theory-based SHE with a CBT-I app using a three-arm randomized controlled trial design.",[28,444],"Adults",[28,446,447,448,444],"Sleep hygiene education","A non-inferiority randomized controlled trial","CBT-I apps","2026-06-07",{"date":323,"type":47},{"date":44,"type":21},{"date":453,"type":21},"2028-06-30",{"name":455,"class":54},"The Hong Kong Polytechnic University",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":464,"minAge":465,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":55},"100603430","phase-4-comparing-digital-therapy-trazodone-and-daridorexant-for-menopause-related-insomnia-symptoms-100603430","NCT07136415","Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms","CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal People","CELESTE","Inclusion Criteria:\n\n* Age 40-62 years\n* Assigned female sex at birth\n* In peri- or early menopause, following the STRAW criteria of self-report of irregular menstrual cycle or within 5 years from the last menstrual period. When menstrual markers are absent or unreliable (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes\n* Insomnia severity index score \\> 10 at screening\n* Insomnia started or worsened during peri- or early menopause\n* English or Spanish speaking (Spanish-only speaking individuals will be recruited after full development of Spanish-facing materials, which may lag initial study start)\n\nExclusion Criteria:\n\n* Untreated, previously diagnosed severe sleep apnea (self-report; chart review; clinician assessment)\n* Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)\n* Severe daytime sleepiness (Epworth Sleepiness Scale \\> 15) at screening\n* Sleep schedule issues that would impact effectiveness of the interventions (e.g., night shift workers with \\>1 night shift\u002Fweek; main sleep period outside of 8pm - 11am)\n* Regular use of hypnotics \\> 2 nights\u002Fweek\n* Limited internet access\n* Pregnant or lactating or positive urine pregnancy test at baseline visit\n* Prolonged QTc interval (\\>460 ms) (by study baseline electrocardiogram (EKG) or EKG report in medical record)\n* History of the following health conditions: Uncontrolled hypertension; clinically significant heart disease such as arrhythmias requiring medication, cardiomyopathies, heart failure, clinically significant valvular heart disease, or severe coronary artery disease (unstable angina, myocardial infarction in the prior 6 months); hypersomnia or narcolepsy; bipolar disorder, severe depression, or psychosis ; seizure within the past year; use of opioids or substance use disorder; known allergy or contraindication to trazodone or daridorexant (self-report and chart review); known severe chronic liver disease (e.g. cirrhosis); end-stage renal disease on hemodialysis; other severe medical comorbidity (e.g. likely hospitalization within next 6 months or medical conditions that increase risk of participation at a study clinician's discretion)\n* Use of medications such as those that: Have known potential for significantly prolonging the QT interval (i.e. antiarrhythmics such as amiodarone, sotalol, quinidine, procainamide, dofetilide, and ibutilide), are strong CYP3A4 inhibitors, or are moderate or strong CYP3A4 inducers\n* Use of one of the interventions in the past 6 months\n* Other conditions determined by the PI or study clinician to preclude study participation","FEMALE","40 Years","62 Years",{"count":468,"type":21},1000,[368],"The goal of this clinical trial is to learn how three current insomnia therapies (trazodone, daridorexant, cognitive behavioral therapy for insomnia) compare with each other in peri- and post-menopausal women. It will also learn about the safety of the treatments. The main questions it aims to answer are:\n\nWhich commonly used insomnia therapies are most effective and safe for improving insomnia symptoms in peri- and post-menopausal people?\n\nHow well do the treatments work for people from different backgrounds, who are at different stages of menopause, and who have different conditions common during menopause (e.g., sleep apnea, mood disturbance, etc.)?\n\nWhat medical problems do participants have when using these treatments?\n\nParticipants will:\n\nBe asked to take trazodone every night, take daridorexant every night, or participate in an online behavioral program for insomnia, for a total of 12 months.\n\nParticipate in a total of one in-person visit and 7 virtual visits (phone calls) over the 12 months.\n\nWear (and keep) a Fitbit and fill out a daily sleep diary for at least 4 weeks over the 12 months.\n\nFill out online surveys 4 times over the 12 months.",[472,28],"Menopausal Women",[474,321,475,476,477],"menopause","cognitive behavioral therapy","trazodone","daridorexant",{"date":424,"type":47},{"date":480,"type":47},"2026-02-13",{"date":482,"type":21},"2031-02",{"name":179,"class":54},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":500,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":78},"100634674","phase-4-a-smart-approach-to-evaluating-the-benefits-of-common-prescription-and-otc-medications-for-insomnia-100634674","NCT07542756","A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia","Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in Adults","Inclusion Criteria\n\n* Adults aged 18-80 years.\n* Meet DSM-5 criteria for Insomnia Disorder.\n* Score ≥15 on the Insomnia Severity Index (ISI).\n* Sleep initiation and\u002For maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights\u002Fweek, with a duration of ≥3 months.\n* Willingness to discontinue use of all sleep-related medications prior to enrollment.\n* Completion of a 2-week washout period before starting any study medication.\n* Willingness to provide clinician assent for participation.\n\nExclusion Criteria\n\nPatients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a history of suicidal attempts or current ideation, acute or chronic psychiatric or medical condition not controlled by therapy (according to their primary care physician), or current alcohol or drug misuse; or the diagnoses of (or high risk for) other sleep disorders, including circadian rhythm disorders (phase advance or phase delay syndromes), shift work related sleep disorder (\"day sleepers\" who work \\~11pm to 7am) and those with rotating shiftwork schedules. To determine eligibility, all subjects will be screened using a multitier process including: an online screener; an intake interview; a review of the subjects EMR; and, finally, the receipt of the patient's PCP's assent. The following provides additional listing and details (AD) for the Exclusion Criteria:\n\nGeneral Considerations\n\n* Age \\\u003C 18 or \\> 80 years old\n* Inadequate English language comprehension\n* Minimal facility with smartphones, computers, i-Pads, or the internet.\n\nWomen's Health Given the potential for teratogenic effects with at least trazodone (FDA Class C), women intending to become pregnant, or who are pregnant, or who are breastfeeding will not be eligible for the study. Women will be asked to confirm the use of birth control using self-report and, if applicable, by providing evidence of contraceptive medication (e.g., prescription or pill pack). We will perform a urine pregnancy test at baseline for female participants who are of reproductive age to confirm eligibility. At study enrollment, participants will be told to alert the study team and stop taking study medications if they become pregnant. Participants will be asked to test for pregnancy in the event of a missed cycle.\n\nMedical and Psychiatric Considerations\n\n* Acute or unstable psychiatric conditions\n* Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.\n* Significant liver or kidney problems\n* Pheochromocytoma or porphyria (contraindicated for trazodone)\n* Epilepsy or Seizure Disorder (contraindicated for trazodone)\n* Glaucoma or urinary retention (contraindicated for doxepin)\n* Increased ocular pressure (contraindicated for diphenhydramine)\n* Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit\n* Inability to refrain from drinking alcohol or substance use for at least 3 consecutive days\n\nSleep Disorders and Sleep Habits\n\n* Any lifetime history of (diagnosis of) breathing disorders, including COPD and sleep apnea.\n* Shift work related sleep disorder (work \\~11pm to 7am and \"day sleeper\") and rotating shiftwork schedules\n* Circadian rhythm disorders (phase advance or phase delay syndromes)\n* Self-reported usual daytime napping ≥1 hour per day (3 or more days per week)\n\nMedications and Concomitant meds\n\n* Known hypersensitivity or contraindication to study drugs\n* Known hypersensitivity or contraindication to drugs of the same class as the study treatments\n* Known hypersensitivity or contraindication to any excipients of the study drug formulation\n* Treatment with CNS active drugs prohibited by the protocol for five half-lives of the respective drug (or 2 weeks)\n\nLifestyle\n\n* Heavy tobacco use (≥1 pack of cigarettes a day or inability to refrain from smoking during the night)\n* Not able or willing to stop treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors","80 Years",{"count":493,"type":21},1200,[368],"The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk\u002Fbenefit profile (doxepin).",[28,497,498,499],"Insomnia Disorder","Chronic Insomnia","Chronic Insomnia Disorder",[31,28,501,502,503,504,505,506],"Zolpidem","Diphenhydramine","Doxepin","Melatonin","Trazodone","Placebo","2026-06-04",{"date":278,"type":47},{"date":510,"type":47},"2026-05-01",{"date":512,"type":21},"2032-01-01",{"name":514,"class":54},"University of Pennsylvania",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":4},"100626812","study-of-bedroom-environment-sleep-intervention-at-home-for-older-adults-living-alone-with-memory-concerns-100626812","NCT07440498","Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns","A Pilot Feasibility Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns","Inclusion Criteria:\n\n* Age 65 years and older\n* Living alone in a private residence or independent living setting ≥5 days\u002Fweek\n* Subjective cognitive decline (Subjective Cognitive Decline Questionnaire MyCog \\> 7\\] OR objective mild cognitive impairment (Montreal Cognitive Assessment \\[MoCA\\] scores between 18-25).\n* Preserved Function (Functional Activity Questionnaire \\\u003C 6)\n* Community-dwelling\n* Self-reported insomnia symptoms\n* Residence in the current home for ≥3 months\n* Expectation to sleep in the designated bedroom on ≥80% of nights during the 8 week protocol\n\nExclusion Criteria:\n\n* Diagnosis of dementia\n* Presence of acute illness or exacerbation of chronic conditions within the past month.\n* Current enrollment in another intervention study",{"count":292,"type":21},[24],"This is an eight-week pilot research study designed to test whether simple changes to the bedroom environment along with brief sleep hygiene strategies, can improve sleep in older adults who live alone, have memory concerns, and experience insomnia symptoms. Older adults may be eligible to participate. The intervention will take 8 weeks, which includes 1-2 in-person visits from the research team at the participant's residence (evaluate the bedroom environment, install participant-agreed bedroom changes, deliver target sleep hygiene strategy) and 2 virtual or telephone calls (support environmental and sleep hygiene strategies) over 8 weeks. Sleep and environment data will be collected at screening\u002Fbaseline, mid-intervention (4-week) and post-intervention (8-week)",[526,527,28],"Subjective Cognitive Decline (SCD)","Mild Cognitive Impairment (MCI)",[321,529,530,531,532,144],"home-based intervention","randomized controlled trial","environmental sensors","community-dwelling older adults",{"date":424,"type":47},{"date":535,"type":21},"2026-10",{"date":537,"type":21},"2028-06",{"name":53,"class":54},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":229},"100562915","phase-2-neural-mechanisms-connecting-deficient-sleep-and-smoking-relapse-100562915","NCT06609369","Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse","Inclusion Criteria:\n\n* English literate\n* report heavy tobacco use (including nicotine e-cigarettes) for \\>6 months\n* meet biochemical cut off for recent cigarette smoking or e-cigarette use\n* optimal body mass index\n\nExclusion Criteria:\n\n* currently enrolled in other treatments\n* neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and\u002For induce deficient sleep\n* medical contraindications for fMRI, varenicline, and\u002For behavioral treatment\n* factors that cause deficient sleep and for which behavioral treatment has less benefit\n* women who are pregnant or nursing",{"count":546,"type":21},114,[164],"The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.",[550,551,28],"Tobacco Use","Tobacco Cessation",{"date":278,"type":47},{"date":554,"type":47},"2025-04-21",{"date":556,"type":21},"2029-06",{"name":558,"class":54},"Yale University",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":565,"maxAge":18,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":78},"100557728","adapted-cbt-i-for-adolescents-with-insomnia--the-dream-it-study-100557728","NCT06541886","Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study","Inclusion Criteria:\n\n* Adolescents (13-18 years) who are in either middle school or high school and meet ICSD-3 diagnostic criteria for Chronic Insomnia Disorder, currently or in the past year, based on self-reported insomnia symptoms, using a screening checklist.\n* Reside in a state where Dr. McQuillan (supervising provider) is licensed to practice psychology (with PsyPact) which are the following states: Alabama, Arizona, Arkansas, Colorado, Commonwealth of the Northern Mariana Islands, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.\n* Sufficient English language proficiency for consent and study participation\n* Reliable internet access to attend virtual visits with audio and video\n* Parents or other caregivers of these adolescents (hereafter referred to as a parent) must live in the home with the identified adolescent at least 50% of the time and must report playing a parental role for that adolescent. The parent must also be able to attend the final 10 minutes of each treatment session, if the teen is randomized to a treatment condition.\n\nExclusion Criteria:\n\n* Sleep aid use that is either inconsistent (e.g., used some but not all nights) and cannot be discontinued OR consistent and effective enough that the teen no longer has insomnia symptoms while using it. If a teen agrees to keep the dose and frequency of sleep aid use consistent throughout the treatment and still has insomnia symptoms at baseline, they are not ineligible.\n* Prior participation in Aim 1 of DREAM IT study (e.g., participation in an Aim 1 focus group).\n* Comorbid medical or psychiatric conditions, including substance use disorders, that are acute, unstable, or untreated. Individuals with Autism Spectrum Disorder, Epilepsy, Schizophrenia, and Bipolar Disorder will be excluded.\n* Comorbid delayed sleep wake phase disorder or other active\u002Funtreated sleep disorders, including RLS, OSA, and Nightmare disorder\n* Active suicidal ideation with plan and intent","13 Years",{"count":567,"type":21},28,[24],"The goal of this study is to test an adapted treatment for teen insomnia in comparison to a waitlist condition. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an intervention that was developed for adults and is sometimes also used for teens. Teens, parents, and health care providers helped to review and adapt CBT-I to form Teen CBT-I. Teen CBT-I includes most of the same content as CBT-I, with some changes to match teen biology and lifestyles.\n\nThe main questions this clinical trial aims to answer are:\n\n* Does Teen CBT-I improve insomnia symptoms in teens?\n\n  o Researchers will compare Teen CBT-I to the waitlist control condition to see if insomnia symptoms significantly improve in the treatment group.\n* Do teens and their parents find Teen CBT-I to be acceptable? o Researchers will examine Teen CBT-I acceptability ratings.\n\nTeen CBT-I is hypothesized to improve insomnia symptoms in teens, and teens and parents are hypothesized to find Teen CBT-I to be acceptable.\n\nTeen participants will be randomized to one of the two conditions: Teen CBT-I treatment or waitlist control. They will also complete assessments at three timepoints: Baseline (before treatment); post-intervention (after treatment); and follow-up (2 months after treatment). For each assessment, teen participants will:\n\n* Fill out questionnaires about their sleep, mood, and other areas\n* Keep daily sleep logs for one week\n* Wear an actigraph, a wrist-watch like device that records activity levels to determine sleep-wake patterns, for one week.\n\nParent participants will also be asked to complete questionnaires at each measurement point about their teen's sleep, mood, and other areas.\n\nThe intervention conditions are:\n\n* Teen CBT-I includes 4-6 one-hour individual virtual sessions with a therapist. It includes standard CBT-I content with some small changes to match teen biology and lifestyles. The main parts of this treatment include healthy sleep habits, only using the bed for sleep, keeping a recommended sleep schedule, changing negative thoughts about sleep, and learning ways to relax the mind and body for sleep.\n* Waitlist-control, in which teens will not receive any treatment for 8 weeks. After the second assessment, they will receive free access to an app-based CBT-I treatment which they can complete on their own.",[28],[41,572,573,574,575,576,577],"Adolescence","Randomized controlled trial","Efficacy","Stakeholders","Adaptation","Actigraphy","2026-06-02",{"date":507,"type":47},{"date":581,"type":47},"2025-04-03",{"date":583,"type":21},"2026-12",{"name":585,"class":54},"Indiana University",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":22,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":604,"locationsCount":78},"100620450","clinical-efficacy-and-health-economic-evaluation-of-an-intelligent-diagnostic-and-treatment-model-100620450","NCT07357779","Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model","Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model Based on Digital Cognitive Behavioral Therapy for Insomnia Disorder","Inclusion Criteria:\n\n* (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.\n\nExclusion Criteria:\n\n* (1) Current use of central nervous system stimulants; (2) Use of analgesics, theophylline preparations, steroid medications; (3) Alcohol abuse or regular alcohol intake; (4) Diagnosis of other sleep disorders (e.g., obstructive sleep apnea, rapid eye movement sleep behavior disorder, restless legs syndrome) ; (5) Sleep disorders secondary to organic diseases (e.g., epilepsy, diabetes, renal failure).",{"count":594,"type":21},200,[24],"The purpose of this study is to evaluate the clinical and cost-effectiveness of an intelligent therapy based on digital cognitive behavioral therapy for insomnia disorders",[28],"2026-06-01",{"date":600,"type":47},"2026-06-03",{"date":602,"type":47},"2026-01-20",{"date":381,"type":21},{"name":605,"class":54},"Zan Wang",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":612,"enrollmentInfo":613,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":624,"leadSponsor":626,"locationsCount":229},"100576686","phase-4-the-effects-of-orexin-antagonism-on-fear-extinction-in-ptsd-100576686","NCT06788522","The Effects of Orexin Antagonism on Fear Extinction in PTSD","Inclusion Criteria:\n\n* (same for Phase 1 and Phase 2):\n\n  * men and women\n  * a history of US military service\n  * capable of reading and understanding English\n  * able to provide written informed consent\n* Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma\n* Chronic full PTSD diagnosis \\>3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score \\> 30\n* Insomnia indicated by insomnia severity index (ISI) score \\> 14\n* Subjects on non-exclusionary medications, and must be on a stable dose for at least 4 weeks prior to randomization, including 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\n\nExclusion Criteria:\n\n* Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months\n\n  * Mild alcohol use disorder with abstinence of 30 days will be allowed\n  * Mild marijuana use disorder will be allowed with abstinence for one week prior to participation\n  * Any other DSM-5 drug use disorder in the last 3 months will be excluded\n* Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features\n* Exposure to trauma in the last 3 months\n* Use of exclusionary antidepressant (trazodone, mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication\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 moderate sleep apnea or positive screen for sleep apnea by type III device (AHI\\>15) in the absence of adherence to effective treatment (such as CPAP or oral device)\n* Night shift work or extreme morning or evening tendencies in order to avoid the impact of circadian factors on subjective and objective sleep measures\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 as assessed by the Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI ID)\n* Uncorrected hearing impairment\n* Mild cognitive impairment assessed by the Montreal Cognitive Assessment (MOCA)\n* Pregnancy, breastfeeding and\u002For refusal to use effective birth control (for women)\n* Previous adverse reaction to a hypnotic\n* Current use of benzodiazepines, strong inhibitors of CYP3A, or Digoxin\n\n  * The investigators will require that all participants do not consume heavy amounts of alcohol per week (\\>7 drinks for women, \\>14 drinks for men) or use illicit drugs for one week prior to participation","75 Years",{"count":614,"type":21},40120,[368],"PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan. Symptoms of PTSD may include re-experiencing, avoidance of trauma reminders, negative thoughts or feelings, and hyperarousal, such as increased startle reactivity and disturbed sleep. Treatments for PTSD are based on fear extinction principles in which individuals are repeatedly exposed a feared cue in the absence of danger, resulting in diminishing physiological reactions, a process believed to underlie recovery from PTSD. Studies suggest that orexin, a wake-promoting neuropeptide, may enhance fear extinction. This study will examine whether suvorexant, a selective orexin-receptor antagonist, will enhance fear extinction in Veterans with PTSD and insomnia. Finding a role for orexins in fear extinction will support the rationale for its further evaluation in the treatment of PTSD. Suvorexant is an accessible, safe medication that has been well-established in treating insomnia. It has outstanding promise for treating common and distressing symptoms in Veterans with PTSD.",[28,618],"PTSD",[620,618,28],"Fear conditioning","2026-05-28",{"date":578,"type":47},{"date":598,"type":21},{"date":625,"type":21},"2032-06-30",{"name":627,"class":628},"VA Office of Research and Development","FED",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":187,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":639,"studyType":640,"phases":4,"briefSummary":641,"conditions":642,"keywords":653,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":678,"locationsCount":78},"100640521","neurofinance-human-stress-trial-during-financial-and-informational-volatility-100640521","NCT07622589","NeuroFinance Human Stress Trial During Financial and Informational Volatility","NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST)","NFHST","Inclusion Criteria:\n\n* Adults age 18 years and older.\n* Ability to provide informed consent.\n* Willingness and ability to comply with study procedures and remote monitoring requirements.\n* Access to a compatible smartphone, tablet, or internet-connected device for decentralized study participation.\n* Willingness to utilize wearable physiologic monitoring technologies during the study period.\n* Participants with varying degrees of financial market exposure, occupational stress exposure, or digital media exposure are eligible.\n* Healthy volunteers and participants with self-reported stress-related symptoms may be enrolled.\n* Ability to read and understand English-language consent and study materials.\n\nExclusion Criteria:\n\n* Individuals unable or unwilling to provide informed consent.\n* Individuals unable to comply with remote monitoring procedures or wearable device usage requirements.\n* Active medical or psychiatric instability that, in the opinion of study investigators, may interfere with study participation or data integrity.\n* Current incarceration or institutionalization limiting voluntary participation.\n* Participation in another interventional clinical trial that may substantially interfere with physiologic monitoring outcomes.\n* Any condition that would significantly impair safe study participation as determined by the study investigators.",{"count":638,"type":21},2500,"24 Months","OBSERVATIONAL","The NeuroFinance Human Stress Trial (NFHST-2026-001) is a decentralized observational clinical study designed to evaluate how financial market volatility, economic uncertainty, digital media exposure, and information-driven stress environments affect human physiologic and behavioral health. Participants will undergo remote monitoring using wearable biosensors, cardiovascular telemetry devices, sleep tracking systems, heart rate variability monitoring, and behavioral analytics platforms. The study will use artificial intelligence and machine learning systems to analyze relationships between external financial and informational events and biologic stress responses, including autonomic nervous system activity, sleep disruption, cardiovascular strain, emotional resilience, and inflammatory signaling. The goal of the study is to develop predictive digital biomarkers and AI-assisted forecasting systems capable of identifying stress-related physiologic deterioration before clinical manifestation.",[643,242,644,645,194,28,646,647,648,649,650,651,652],"Psychological Stress","Emotional Stress","Autonomic Nervous System Dysfunction","Behavioral Health","Cognitive Fatigue","Occupational Stress","Financial Stress","Burnout Syndrome","Heart Rate Variability","Neurobehavioral Manifestations",[654,655,656,657,658,659,651,660,661,662,663,664,665,666,667,668,669,670,671,672],"NeuroFinance","Financial Stress Medicine","Wearable Biosensors","Artificial Intelligence","Machine Learning","Digital Biomarkers","Sleep Monitoring","Behavioral Analytics","Cardiovascular Telemetry","Decentralized Clinical Trial","Emotional Resilience","Physiologic Stress","Market Volatility","Economic Uncertainty","Social Media Exposure","Cognitive Performance","Stress Forecasting","Precision Wellness","Remote Patient Monitoring","2026-05-27",{"date":600,"type":47},{"date":676,"type":21},"2026-07-15",{"date":127,"type":21},{"name":679,"class":680},"Truway Health, Inc.","INDUSTRY"]