[{"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,227,0,25,[9,52,77,125,146,169,193,213,241,265,286,308,330,354,383,406,427,450,476,497,519,542,571,598,618],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100646079","efficacy-of-cbt-i-with-adjuvant-melatonin-in-older-adults-chronic-insomnia-100646079",false,"NCT07695246","Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia","Efficacy of Cognitive Behavioural Therapy for Insomnia With Adjuvant Melatonin Treatment in Older Adults With Chronic Insomnia: A Randomised Controlled Trial","SOAM","Inclusion Criteria:\n\n1. Chinese aged ≥ 60.\n2. Provision of written informed consent.\n3. Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress).\n4. Having a score of \\> 14 on the ISI, indicating clinical insomnia.\n\nExclusion Criteria:\n\n1. Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.\n2. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).\n3. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).\n4. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder.\n5. Having mild to significant cognitive impairment, defined by having a score of \\\u003C 22 on MOCA.\n6. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).\n7. Receiving concurrent psychological treatment for insomnia.\n8. Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).\n9. Being a night shift worker.","ALL","60 Years",{"count":21,"type":22},183,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.",[28,29,30],"Insomnia","Aging","Sleep Disorders",[28,32,33,34,35,36,37,38],"Elderly","CBT","Melatonin","Circadian Rhythm","Sleep","Randomised controlled trial","Older adults","RECRUITING","2026-08-20",{"date":42,"type":43},"2026-08-21","ACTUAL",{"date":45,"type":43},"2026-08-01",{"date":47,"type":22},"2029-08-01",{"name":49,"class":50},"The University of Hong Kong","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":51},"100625298","phase-2-efficacy-and-safety-of-apstzd-in-the-treatment-of-insomnia-disorder-100625298","NCT07420816","Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder","Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder","TINA","Inclusion Criteria:\n\n* Participants aged between 18 and 64 years;\n* Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;\n* Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).\n\nExclusion Criteria:\n\n* Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;\n* Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;\n* Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;\n* Participants diagnosed with severe liver failure;","18 Years","64 Years",{"count":63,"type":22},222,[65],"PHASE2","The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.",[28,68],"Insomnia Chronic",{"date":42,"type":43},{"date":71,"type":43},"2026-08-05",{"date":73,"type":22},"2027-12",{"name":75,"class":76},"Apsen Farmaceutica S.A.","INDUSTRY",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":18,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"0 Years","20 Years",{"count":89,"type":22},5000,"OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[93,94,95,96,97,98,99,100,101,102,103,104,28,105,106,107,108,109,110,111,112,113,114,115,116],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome",{"date":42,"type":43},{"date":119,"type":43},"2020-03-05",{"date":121,"type":22},"2026-12",{"name":123,"class":50},"Duke University",52,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100651676","photobiomodulation-for-reducing-sedative-hypnotic-useclinical-trial-of-a-light-therapy-device-100651676","NCT07764107","Photobiomodulation for Reducing Sedative-Hypnotic Use:Clinical Trial of a Light-Therapy Device","Photobiomodulation for Reducing Sedative-Hypnotic Use: Clinical Trial of a Light-Therapy Device","Inclusion Criteria:\n\n* A Pittsburgh Sleep Quality Index (PSQI) score of 8 or above.\n* Currently taking sedative-hypnotic medications at least 4 days per week.\n\nExclusion Criteria:\n\n* Having a movement disorder, including Parkinson's disease or moderate to severe dementia, resulting in inability to ambulate independently.\n* Having major psychiatric comorbidities, such as bipolar disorder or schizophrenia, or a Beck Depression Inventory-II (BDI-II) score greater than 13.\n* A history of sleep disorders, such as obstructive sleep apnea or periodic limb movement disorder.\n* Currently undergoing adjustment of sleep medications in clinical care.\n* Skin damage or active dermatologic conditions at the irradiation site.\n* Night-shift workers or individuals unable to maintain regular nighttime sleep for other reasons.\n* Pregnant women.","100 Years",{"count":134,"type":22},60,[25],"Background: Insomnia is a prevalent and growing public health issue, with one in three adults affected globally and one in five Taiwanese adults reporting significant sleep disturbances. Long-term use of sedative-hypnotic medications remains common in Taiwan despite clinical guidelines recommending short-term use only, contributing to adverse outcomes such as impaired sleep architecture, cognitive deficits, and elevated dementia risk. Non-pharmacological interventions-particularly light-based therapies-offer promising alternatives but existing bright-light therapy is limited by melatonin suppression and the need for precise daytime timing. Recent advances in photobiomodulation (PBM) suggest that red and near-infrared light, which do not suppress melatonin, may enhance sleep quality and support glymphatic clearance when applied during sleep. Preliminary findings from our prior NSTC-funded industry-academia project demonstrated that 850-nm PBM applied during sleep improved subjective sleep quality and sleep duration among older adults with insomnia who were not using hypnotics. Building on these results, the present study aims to evaluate whether sleep-period PBM can improve sleep quality, enhance daytime alertness and cognitive function, and reduce sedative-hypnotic medication use among adults with chronic insomnia who regularly use these medications.\n\nMethods: The study will employ an 8-week, single-blind, randomized controlled trial with two parallel arms: (1) PBM intervention and (2) inactive sham control. We will develop an engineer-certified wearable PBM prototype integrating near-infrared LEDs. Sixty adults who use sedative-hypnotics ≥4 days per week will be recruited. Participants will be randomized in a 1:1 ratio and instructed to use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period. Outcomes will be assessed at baseline, week 4, and week 8. Primary outcomes include changes in subjective sleep quality (PSQI), hypnotic use frequency, and objective sleep parameters measured by wrist actigraphy. Secondary outcomes include daytime sleepiness (KSS), emotional symptoms (BDI and BAI), and psychomotor vigilance task performance.\n\nExpected contributions: This study is expected to generate clinical evidence in Taiwan evaluating nighttime PBM for insomnia in hypnotic-using populations, address the unmet need for portable, home-based, non-pharmacological sleep interventions, and support future commercialization of a sleep-compatible light therapy device. Results will inform device optimization, regulatory approval strategies, and market expansion efforts in the growing global sleep-health industry.",[28],"NOT_YET_RECRUITING","2026-08-19",{"date":42,"type":43},{"date":45,"type":22},{"date":143,"type":22},"2027-05-05",{"name":145,"class":50},"National Health Research Institutes, Taiwan",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100652790","group-based-brief-behavioral-therapy-for-insomnia-for-patients-with-chronic-mental-illness-100652790","NCT07779499","Group-Based Brief Behavioral Therapy for Insomnia for Patients With Chronic Mental Illness","Effectiveness of a Group-Based Brief Behavioral Therapy for Insomnia for Patients With Chronic Mental Illness","Inclusion Criteria:\n\n* Aged 18 years and older.\n* Diagnosed with a psychiatric disorder.\n* Experiencing self-reported sleep disturbances, such as difficulty initiating sleep, difficulty maintaining sleep, early morning awakening, prolonged sleep latency, short sleep duration, poor sleep efficiency, or the current use of sedative-hypnotic medications.\n\nExclusion Criteria:\n\n* Severe intellectual disability resulting in the inability to complete the assessment questionnaires.\n* Severe cognitive impairment (e.g., dementia) that prevents cooperation and participation in the intervention activities.\n* Recent clinical instability, high suicide risk, or deemed unsuitable for participation by the primary attending physician.",{"count":154,"type":22},120,[25],"The goal of this clinical trial is to evaluate the effectiveness of a short-term, group-based Brief Behavioral Therapy for Insomnia (BBTI) intervention in chronic psychiatric patients at a hospital day ward.The main questions it aims to answer are:\n\n1. Does the BBTI-based group intervention improve subjective sleep quality and reduce the severity of insomnia?\n2. Does the intervention have a positive effect on psychological well-being and cardiometabolic\u002Fphysical functions? Researchers will compare an experimental group to a waitlist control group to see if the intervention improves sleep quality, reduces insomnia-perpetuating behaviors, and enhances overall health status across various timeframes.\n\nParticipants will:\n\n1. Attend four sessions that cover sleep structure education, relaxation techniques (including acupressure), sleep-promoting diet principles, and the proper use of sedative-hypnotic medications.\n2. Write a daily sleep diary.\n3. Complete three times of structured self-report questionnaires.\n4. Undergo physiological and physical function assessments.",[28],[159,160],"brief behavioral treatment of insomnia","insomnia","2026-08-18",{"date":42,"type":43},{"date":164,"type":22},"2026-08-31",{"date":166,"type":22},"2026-11-10",{"name":168,"class":50},"National Taiwan University Hospital",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":51},"100565151","clinical-trial-for-acupuncture-in-adolescents-with-psychological-distress-and-insomnia-100565151","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":179,"type":22},148,[25],"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.",[183,28],"Psychological Distress",[185,28,186,187],"Psychological distress","Acupuncture","Adolescent",{"date":40,"type":43},{"date":161,"type":43},{"date":191,"type":22},"2028-09",{"name":49,"class":50},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":18,"minAge":200,"maxAge":19,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":51},"100494225","assessment-of-light-therapy-in-insomnia-disorder-100494225","NCT05715411","Assessment of Light Therapy in Insomnia Disorder","InsomLum","Inclusion Criteria:\n\n* Patient aged 30 to 60 years\n* Insomnia disorders (ICSD-3) with sleep latency \\>30min - 3 times a week\n* Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent\n* Patient affiliated to a social health insurance scheme\n* For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD).\n\nExclusion Criteria:\n\n* \\- Shift work in the year preceding inclusion\n* Trans meridian travel (\\> 2 time zones) in the month preceding inclusion\n* Patient in exclusion period determined by a previous or ongoing study\n* Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)\n* Patient under judicial protection\n* Patient under guardianship or curatorship\n* For a woman of childbearing age: ongoing pregnancy or breastfeeding\n* Drug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin.\n* Phase delay syndrome defined according to the criteria of the international classification of ICSD-3\n* Restless legs syndrome with IRLS score\\> 20\n* Other psychiatric disorders or addictive disorder (screening with the MINI structured interview)\n* Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion:\n\n  * Chronic allergies\n  * Neurological disorders\n  * cardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseases\n  * diseases of the immune system\n  * kidney and urinary tract diseases\n  * endocrine and metabolic diseases\n  * infectious diseases\n  * epilepsy","30 Years",{"count":202,"type":22},66,[25],"Sleep disorders represent a major public health issue and the leader in these disorders is insomnia with 10 to 15% of subjects in the general population reporting symptoms of insomnia with a daytime impact. In addition to being very common, insomnia leads to an increase in morbidity and mortality and weighs on healthcare systems worldwide. Despite this public health context, insomnia is underdiagnosed and rarely treated. Hypnotics have proven efficacy but with a risk of dependence and pharmacotolerance which appears within a few weeks. Cognitive behavioral therapy (CBT) has a good level of evidence and is now a benchmark treatment for the management of insomnia. Unfortunately, not all patients adhere to or respond to these procedures, which cannot be implemented for many of them either. There is therefore a need to identify other alternative therapeutic strategies, and we believe that exposure to light is a promising treatment.\n\nIn this perspective, it seems interesting to assess the effect of the propensity to fall asleep with an exposure to light therapy in patients suffering from insomnia.\n\nIn order to be in optimal ecological conditions, we want to use a portable light therapy device which allows easy, acceptable and ambulatory exposure.\n\nIf the lighttherapy is confirmed in insomnia under ecological conditions, this would make it possible to propose a new non-drug treatment, easy to access and on a large scale",[28],{"date":40,"type":43},{"date":208,"type":43},"2024-11-28",{"date":210,"type":22},"2027-08",{"name":212,"class":50},"University Hospital, Strasbourg, France",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":51},"100624141","sleepfix-for-youth-digital-behavioural-therapy-for-insomnia-with-e-psychologist-support-100624141","NCT07405775","SleepFix for Youth: Digital Behavioural Therapy for Insomnia With E-Psychologist Support","iSLEEPY","Inclusion Criteria:\n\n* 16 -24 years old\n* Able to give informed online consent and if younger \\\u003C18years old guardian\u002Fparental consent\n* Insomnia Severity Index ≥ 10\n* English fluency\n* Access to a smartphone and willingness to use a mobile app for healthcare\n\nExclusion Criteria:\n\n* Shift-workers with regular shifts between the hours of 8pm and 8am.\n* Recent travel to a destination with \\>2 hours time difference (within last 7-days and with subjective reports that they are not experiencing jet lag).\n* Serious medical and\u002For psychiatric illnesses\u002Fdisorders (e.g., Epilepsy or other seizure disorders, heart failure, bipolar disorder, schizophrenia, Major Depressive disorder)\n* Self-reported\u002Fdiagnosed sleep disorders other than insomnia (e.g. - Obstructive Sleep Apnoea, REM\u002FNREM sleep disorders, Restless Leg Syndrome, Narcolepsy, free running cycle \\& Circadian rhythm disorder)\n* Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).\n* Pregnant\n* Professional driver or operate heavy machinery","16 Years","24 Years",{"count":223,"type":22},40,[25],"This pilot randomised, open-label, parallel-group controlled trial will evaluate the feasibility, acceptability and effects of a psychologist-supported digital behavioural therapy for insomnia (dBTi) compared to a wait-listed active control (digital sleep health education) in young people aged 16-24 years with insomnia symptoms.\n\nThe primary objectives are to evaluate the feasibility of conducting a full-scale trial by assessing recruitment, consent and randomisation rates, intervention uptake, and data completeness. Secondary objectives include exploring treatment effects on insomnia severity (Insomnia Severity Index), sleep diary metrics, sleep quality, fatigue, and mood (depression and anxiety symptoms). Post-intervention interviews will assess participant experience and acceptability.\n\nResults will inform the design of a larger randomised controlled trial.",[28],[228,229,160,230,231,232],"young people","adolescents","CBTi","digital behavioural therapy for insomnia","sleep restriction therapy","2026-08-17",{"date":139,"type":43},{"date":236,"type":43},"2026-04-10",{"date":238,"type":22},"2027-11-01",{"name":240,"class":50},"Woolcock Institute of Medical Research",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":200,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":51},"100623095","phase-2-understanding-the-role-of-the-locus-coeruleus-in-insomnia-100623095","NCT07392177","Understanding the Role of the Locus Coeruleus in Insomnia","An Alpha2-adrenoceptor Agonist to Reduce Locus Coeruleus Activity During Sleep in Adults With Insomnia Disorder: a Pilot Randomised Placebo-controlled Cross-over Study","LOCUSleep","Inclusion Criteria:\n\n* Diagnosis of insomnia disorder (DSM-5-TR)\n* Insomnia severity index (ISI) score ≥15\n* Able to provide informed consent\n* Fluent English literacy\n\nExclusion Criteria:\n\n* Medically diagnosis of sleep disordered breathing (i.e. sleep apnea) or sleep or circadian disorder other than insomnia\n* Uncontrolled psychiatric disorders\n* High dependence on medical care\n* History of, or current suicide ideation (Patient Health Questionnaire (PHQ-9) questionnaire)\n* Pregnancy or actively trying to conceive, or lactating\n* Shiftwork - defined as work outside of business hours (before 8am or after 6pm) conducted at least once per week\n* Travel across time zones of over 2 h time difference in the past week\n* Contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures\n* Concomitant use of medicines that are inhibitors, or moderate to strong inducers, of CYP3A4; regular use of hypnotics and other medications that can cause additive sedation or psychostimulants or non-amphetamine psychostimulants within 14 days of starting the clinical trial\n* Ongoing use of THC- or CBD-containing products; dependence or any other drug or alcohol dependence\n* Allergy to lactose","65 Years",{"count":251,"type":22},15,[65],"This research project aims to better understand the neurobiological mechanistic underpinnings of insomnia disorder. The main question is whether cortical hyperarousal in individuals with insomnia disorder, measured by electroencephalograhic (EEG) infraslow oscillation coupling of sigma power during non-rapid eye movement (NREM) sleep and theta power during rapid eye movement (REM) sleep, is related to locus coeruleus activity.",[28],[256,36,257,258],"Electroencephalography","Locus coeruleus","Hyperarousal",{"date":139,"type":43},{"date":261,"type":43},"2026-08-12",{"date":263,"type":22},"2027-03",{"name":240,"class":50},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":249,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":51},"100652251","efficacy-of-internet-based-cognitive-behavioral-therapy-for-insomnia-in-patients-with-tinnitus-and-insomnia-100652251","NCT07769515","Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia","A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia","Inclusion Criteria:\n\n* Adults aged between 18 and 65 years;\n* Diagnosis of chronic subjective tinnitus persisting for at least 6 months;\n* A score of 38 or higher on the Tinnitus Handicap Inventory (THI);\n* An Insomnia Severity Index (ISI) score of 8 or higher;\n* Ability to understand the study procedures and provide informed consent;\n* Proficiency in reading and writing Chinese;\n* Access to a smartphone for participation in the digital intervention.\n\nExclusion Criteria:\n\n* Objective or pulsatile tinnitus;\n* Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss;\n* Diagnosed organic sleep disorders, such as obstructive sleep apnea;\n* Serious psychiatric disorders, including schizophrenia;\n* Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.",{"count":273,"type":22},168,[25],"This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia. A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention. The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization. Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep. Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.",[277,28],"Tinnitus","2026-08-13",{"date":161,"type":43},{"date":281,"type":22},"2026-08-24",{"date":283,"type":22},"2029-12-30",{"name":285,"class":50},"Eye & ENT Hospital of Fudan University",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":51},"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* Cardiac tachycardia (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","50 Years",{"count":223,"type":22},[25],"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.",[298,28,299],"Survivor of Childhood Cancer","Acute Lymphoblastic Leukemia (ALL)",{"date":301,"type":43},"2026-08-14",{"date":303,"type":43},"2026-03-31",{"date":305,"type":22},"2029-12",{"name":307,"class":50},"St. Jude Children's Research Hospital",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100566492","phase-3-a-study-of-suvorexant-mk-4305-for-the-treatment-of-insomnia-disorder-in-participants-with-opioid-use-disorder-mk-4305-098-100566492","NCT06655883","A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a primary diagnosis of OUD according to Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5), and confirmed through the Mini International Neuropsychiatric Interview (MINI).\n* Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment.\n* Meets DSM-5 criteria for the diagnosis of Insomnia Disorder\n* Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study.\n* Has not used opioids for a period of at least 4 weeks before entering the study.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has current uncontrolled major co-morbid psychiatric illness including major depressive disorder, bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features.\n* Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (EDS), or primary hypersomnia.\n* Is at imminent risk of self-harm.\n* Has a known history of stroke that may confound the diagnosis of insomnia.\n* Has a clinically significant movement disorder such as akinesia.\n* Has a history of hepatitis or live disease.\n* Has habitual use of central nervous system (CNS)-depressants or stimulants that may be responsible for the participant's disturbed sleep.\n* Has a history of malignancy, ≤3 years prior to start of study, with the exception of nonmelanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix.\n* Has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications.\n* Has donated blood products or had phlebotomy within 8 weeks prior to start of study.\n* Has a history of transmeridian travel within 2 weeks prior to start of study.","70 Years",{"count":317,"type":22},300,[319],"PHASE3","People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.",[28],{"date":301,"type":43},{"date":324,"type":43},"2025-10-09",{"date":326,"type":22},"2027-06-24",{"name":328,"class":76},"Merck Sharp & Dohme LLC",12,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":337,"maxAge":221,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":51},"100652021","efficacy-of-cognitive-behavioural-therapy-for-insomnia-and-bright-light-therapy-in-adolescents-with-adhd-insomnia-and-evening-chronotype-100652021","NCT07767617","Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD, Insomnia, and Evening Chronotype","Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD and Comorbid Insomnia and Evening Chronotype: A Randomised, Assessor Blind, Parallel-group Trial","Inclusion criteria:\n\nAn adolescent who meets the following criteria will be eligible for taking part in this study:\n\n1. aged 10-24 years old;\n2. ADHD diagnosis confirmed by DISC-IV;\n3. DSM-5 diagnosis of insomnia disorder with an ≥ 9 (suggested cut-off for adolescents);\n4. Being classified as evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, 12:00am or later for 15-17 years old \\[64\\], 10:56pm or later for 18-24 years old at least 3 nights per week in the past 3 months and as confirmed by a 7-day sleep diary;\n5. Written informed consent from the participant and their parent\u002Fguardian (for those aged under 18);\n6. Being able to comply with the study protocol;\n7. Either not on ADHD medication or stabilized on medications for at least 6 months.\n\nExclusion criteria:\n\nAn adolescent who meets one or more of the following criteria will be excluded from the study:\n\n1. Substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia, ASD, organic mental disorders, or intellectual disabilities;\n2. Prominent medical condition affecting sleep (e.g., severe eczema, GERD);\n3. Clinically diagnosed sleep disorder other than insomnia disorder, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;\n4. Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both prescribed medications (e.g., hypnotics, steroids) and over-the-counter OTC medications (e.g., melatonin, Traditional Chinese Medicine, TCM), except for ADHD stimulants;\n5. Ongoing psychological treatment for sleep problems;\n6. With hearing or speech deficit;\n7. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt).","10 Years",{"count":339,"type":22},150,[25],"Attention-deficit\u002Fhyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by persistent inattention, hyperactivity, and impulsivity. In adolescents and young people, ADHD is commonly accompanied by insomnia and circadian delay. These co-occurring sleep and circadian disturbances may negatively affect daytime functioning and overall clinical outcomes. Although cognitive behavioural therapy for insomnia (CBT-I) is considered the first-line treatment for insomnia, and bright light therapy may help address circadian issues, their efficacy in adolescents with ADHD and comorbid insomnia and eveningness remains unexplored. This study aims to evaluate whether CBT-I, with or without bright light therapy, improves insomnia, sleep, and circadian as well as other clinical outcomes, and cognitive functioning in youths with ADHD and whether these interventions can also lead to improvements in mood and other clinical symptoms, as well as cognitive functioning.",[28,343,344,345,346],"ADHD","Eveningness","Chronotype","Treatment Effectiveness","2026-08-11",{"date":233,"type":43},{"date":350,"type":22},"2026-08-10",{"date":352,"type":22},"2029-08-31",{"name":49,"class":50},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":85,"sex":18,"minAge":60,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":370,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":51},"100643151","does-style-matter-comparison-of-moderate--to-low-intensity-styles-of-yoga-100643151","NCT07638267","Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga","Effects of a Single Evening Session of Vinyasa Yoga to Gentle Yoga on Sleep and Cardiovascular Health in Adults","Inclusion Criteria:\n\n* Adults 18-40 years\n* Insufficiently inactive define by the L-CAT (responses below public health physical activity guidelines)\n* Physical activity is not contraindicated (i.e., no affirmative responses on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)\n* Adults with diagnosed insomnia disorder and score ≥ 10 on the Insomnia Severity Index\n* Good sleeps a score \\\u003C 10 (no history of sleep disorder)\n* Basic understanding of yoga poses\n* Access to a smart device (such as a smartphone or tablet)\n\nExclusion Criteria:\n\n* Regular yoga practice (\\> 60 minutes per week)\n* Any diagnosed medical condition requiring medical clearance determined 'Yes' response on questions pertaining to a present medical condition(s) via PAR-Q+. This includes, but is not limited to, uncontrolled cardiovascular, metabolic, respiratory, musculoskeletal, neurological, or mental health conditions; recent stroke or concussion; active cancer treatment; and any combination of medical conditions that pose a health risk without physician supervision. All \"yes\" responses on the PAR-Q+ will be evaluated, and individuals requiring clearance will not be eligible to participate.\n* Physical limitations and\u002For mobility restrictions (such as bone, joint, or soft tissue such as muscle, ligament, or tendon that could be made worse by becoming more physically active) via PAR-Q+\n* Untreated major psychiatric disorders (e.g. major depression, bipolar disorder, schizophrenia)\n* Elevated risk for sleep apnea (i.e., STOP-Bang score ≥ 5)\n* Any other sleep disorders other than insomnia (e.g., sleep apnea, restless legs syndrome, circadian rhythm disorder, etc.)\n* Current treatment for insomnia (e.g., hypnotic medications, cognitive behavioral therapy for insomnia, etc.)\n* Current medications that affect heart or blood pressure (i.e., anti-depressants, beta-blockers, etc.)\n* Current or planned pregnancy within the next 3 months\n* Overnight shift work defined as regularly working anytime between 00:00 and 6:00am","40 Years",{"count":363,"type":22},42,[25],"The goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are:\n\n* Does the style of yoga impact participants heart health overnight?\n* Does the style of yoga improve participants sleep following a single session? Researchers will compare adults with insomnia disorder to adults with healthy sleep .\n\nParticipants will:\n\n* Complete a moderate-intensity yoga practice, a low-intensity intensity yoga practice, and a quiet rest period while watching a nature documentary in the evening on three separate evenings\n* Participants will have their sleep and heart health measured using a watch and heart rate monitor overnight following each visit",[28,367,368,369],"Health Adult Subjects","Insomnia Disorder","Heart Health Markers",[371,160,372,373,374,375],"sleep","yoga","heart health","heart rate variability","actigraphy",{"date":278,"type":43},{"date":378,"type":43},"2026-06-01",{"date":380,"type":22},"2026-09",{"name":382,"class":50},"Caitlin Cheruka",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":405},"100524542","multi-center-trial-to-improve-nocturia-and-sleep-in-older-adults-100524542","NCT06110091","Multi-center Trial to Improve Nocturia and Sleep in Older Adults","Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)","MINT","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Average of ≥ 2 episodes per night of nocturia on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire\n* Insomnia Severity Index \\> 7\n* Able to attend weekly study visits\n\nExclusion Criteria:\n\n* Prior cognitive behavioral therapy for insomnia\n* Presence of bipolar disorder\n* Significant cognitive impairment as measured by a score \\\u003C 20 on the Mini-Mental State Exam\n* Sleep disturbance better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders\n* Untreated sleep-disordered breathing (respiratory event index ≥ 15 plus • Epworth Sleepiness Scale \\> 10 or respiratory event index \\> 30. Note that participants with treated sleep-disordered breathing will not be excluded)\n* Current urinary tract infection or hematuria\n* Unstable doses or recent changes in bladder medication\n* New or recently discontinued insomnia medication within past month\n* Previous or current intensive behavioral therapy for insomnia or urinary symptoms,\n* Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by overall study PIs or Site PI.\n* Unstable medical conditions that could contribute to nocturia or insomnia such as poorly controlled heart failure as evidenced on physical examination, poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 9.0, or chronic kidney disease (stage 4 or 5) or a potential to initiate dialysis in 3 months\n* Unstable psychiatric conditions (e.g., psychosis, active alcohol\u002Fsubstance abuse based on history and medical records)\n* Unstable housing situation\n* Evidence of significant urinary retention as measured by a residual bladder volume of ≥ 200 mL by bladder ultrasound with 15 minutes of voiding\n* Genitourinary cancer undergoing active treatment\n* Pelvic or colon surgery within 6 months of enrollment or onabotulinum toxin therapy for urinary symptoms within 6 months of enrollment",{"count":392,"type":22},192,[25],"The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.",[396,28],"Nocturia",{"date":278,"type":43},{"date":399,"type":43},"2023-12-05",{"date":401,"type":22},"2028-08",{"name":403,"class":404},"Atlanta VA Medical Center","FED",2,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":413,"minAge":249,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":51},"100651444","addressing-nocturia-in-older-women-utilizing-behavioral-sleep-intervention-and-brief-mindfulness-100651444","NCT07760779","Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness","ANOWSM","Inclusion Criteria:\n\n* Female\n* Age \\> or =65 years\n* Nocturia ≥2\u002Fnight\n* Poor sleep (Insomnia Severity Index ≥8)\n* MoCA (including trail making) \\>26\n\nExclusion Criteria:\n\n* Conditions that affect bladder function: Multiple sclerosis, Alzheimer's disease, spinal cord injury, urethral obstruction, urinary retention, interstitial cystitis, bladder cancer, radiation to the pelvic area, bladder surgery, current or uncontrolled chronic or recurrent bowel issues, bacterial endocarditis\n* cardiac or respiratory disease that limits daily function\n* Unstable or acute medical condition:\n\n  \\- Any acute medical condition that requires immediate treatment such that it would interfere with the study protocol; Each instance will be assessed on a case-by-case basis by our study physician who may postpone a participant's enrollment; stably managed chronic conditions are exempt from this exclusion.\n* Untreated, current, severe psychiatric condition (assessed during Visit 1a- medical history)\n* Post void residual ≥ 200ml- assessed during baseline visit\n* Currently diagnosed and\u002For untreated obstructive sleep apnea, untreated restless leg syndrome, untreated parasomnia\n* Untreated or poorly controlled fluid overload conditions like CHF, diabetes","FEMALE",{"count":415,"type":22},80,[25],"The goal of this clinical trial is to examine and compare the effect of behavioral sleep treatment: BBTI (brief behavioral treatment of insomnia) and brief mindfulness (MI), independently and combined vs control on frequency of nighttime awakenings to void (nocturia) and on nighttime urine production in older women over the age 65 years with nocturia.\n\nTo study the effect of these treatments, participants will be randomly assigned to one of the following groups 1) BBTI alone, 2) MI alone, 3) BBTI+MI, or 4) control: sleep information only without any structured sleep or mindfulness therapy.\n\nThe study aims to examine the effect of these therapies at end-of-treatment (week 4), as well sustained effects at 3- and 6-months. The main questions the study aims to answer are:\n\n1. do these treatments reduce the frequency of nighttime awakenings to void\n2. do these treatments reduce the volume of nighttime urine production\n3. do these treatments improve sleep quality\n\nFrequency of nocturia and sleep quality will be assessed via questionnaires and nighttime urine volume using bladder-sleep diaries which is 3-day record participants will complete at home documenting every time they go to the bathroom and volume they voided. In addition, sleep and sleep interruptions will also be assessed using an FDA-cleared home sleep testing device called Zmachine®.",[396,28],"2026-08-07",{"date":261,"type":43},{"date":422,"type":22},"2026-09-15",{"date":424,"type":22},"2029-04-30",{"name":426,"class":50},"University of Pittsburgh",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":85,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":51},"100650902","the-wise-study-whatsapp-intervention-for-sleep-in-the-elderly-100650902","NCT07751458","The WISE Study (WhatsApp Intervention for Sleep in the Elderly)","The WISE Study (WhatsApp Intervention for Sleep in the Elderly): Targeting Insomnia and Loneliness With a Digital Booklet","WISE","Inclusion Criteria:\n\n* Elderly individuals diagnosed with loneliness\n* Reported experiencing sleep disturbances in the past 2 weeks, either continuously or intermittently\n* Experiencing insomnia with a total score of ≥ 8 on the Indonesian version of the Insomnia Severity Index (ISI) during screening\n* Able to communicate in Indonesian\n\nExclusion Criteria:\n\n* Elderly individuals with dementia, delirium, severe mental retardation, or cognitive impairment that prevents them from understanding or assessing their own sleep experience.\n* Currently using new sleeping medication\u002Fstimulants",{"count":436,"type":22},50,[25],"Sleep hygiene education is an educational effort to teach healthy sleep habits and behaviors to improve sleep quality, duration, and regularity naturally without the use of medication; however, this approach has not been established in Indonesia. This study aims to establish a sleep hygiene education care model among lonely older adults with insomnia in Indonesia and to examine the immediate effects of the WISE Study (WhatsApp Intervention for Sleep in the Elderly) led by nurses to older adults loneliness with insomnia using a Digital Booklet. In this assessor-blinded, randomized controlled trial, participants will be randomly allocated to either the nurse-led WISE experimental group or the control group provided with usual care. The outcomes will include sleep parameters measured using the Indonesian version of the Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), Geriatric Depression Scale-Short Form (GDS-SF), Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale (ESS), and sleep diaries. The questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. Generalized estimating equations will be used to test the research hypotheses. Questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. We hypothesized that older adults who were loneliness with insomnia who underwent nurse-led WISE would experience greater improvements in sleep quality compared to participants in a control group who received usual care.",[440,28],"Loneliness",[442,38,440,28],"WiSE",{"date":419,"type":43},{"date":445,"type":22},"2026-07-30",{"date":447,"type":22},"2026-12-03",{"name":449,"class":50},"Halu Oleo University",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":249,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":51},"100650992","qing-xin-jiao-tai-decoction-for-insomnia-comorbid-with-obesity-presenting-with-heart-kidney-non-interaction-syndrome-100650992","NCT07754383","Qing-Xin-Jiao-Tai Decoction for Insomnia Comorbid With Obesity Presenting With Heart-Kidney Non-interaction Syndrome","Intelligent Diagnosis and Effective Prescription Verification of Sleep Disorders Complicated With Obesity Based on Disease-syndrome Combination","Inclusion Criteria:\n\n* Individuals who meet both diagnostic criteria for sleep disorders and obesity, and have a Pittsburgh Sleep Quality Index (PSQI) score exceeding 7\n* Meet the TCM syndrome differentiation criteria for either the heart-kidney disharmony syndrome or the liver-fire disturbing the heart syndrome\n* Aged 18-65, male or female\n* Those who can actively cooperate with oral Chinese medicine treatment\n* Voluntarily accept this study and sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with severe cardiovascular and cerebrovascular diseases, hematological system diseases, severe liver and kidney dysfunction, tumors, and other severe organic diseases\n* Individuals with a history of allergy to the study drug or with an allergic constitution\n* Women planning to become pregnant, pregnant, or breastfeeding\n* Currently taking or having taken sedative traditional Chinese patent medicines and simple preparations within 4 weeks prior to enrollment, or having used semaglutide and other GLP-1 receptor agonists or weight-reducing preparations with long-term weight-loss effects within 12 weeks prior to enrollment\n* Those with severe cognitive dysfunction or unable to take care of themselves and therefore unable to cooperate with the clinical trial protocol\n* Patients with severe anxiety, depression \\[Self-rating Anxiety Scale (SAS) score ≥70, Self-rating Depression Scale (SDS) score ≥73\\], mania, schizophrenia, and suicidal tendencies.\n* Individuals who are severely allergic to PSG electrode patches, or who cannot cooperate with polysomnography (PSG) and heart rate variability (HRV) testing due to work\u002Flifestyle habits",{"count":458,"type":22},72,[460],"EARLY_PHASE1","This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Qing-Xin-Jiao-Tai Decoction (QXJTD), a Traditional Chinese Medicine formula, in treating adults (aged 18-65) suffering from both insomnia and obesity. Specifically, the study targets patients diagnosed with Heart-Kidney Non-interaction syndrome. In this study, 72 eligible participants will be randomly assigned to receive either QXJTD granules or a matching placebo twice daily for 8 weeks. Both groups will concurrently receive a personalized lifestyle intervention program that includes structured dietary and exercise guidance. The primary purpose of this research is to determine if QXJTD combined with lifestyle modifications can significantly improve sleep quality and promote weight loss compared to the placebo. The primary endpoints evaluated will be objective sleep parameters measured via overnight polysomnography, the percentage of body weight lost, and subjective sleep improvements assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI). By evaluating these outcomes, the researchers hope to provide a safe and effective integrative treatment strategy for patients struggling with this complex comorbidity.",[28,463],"Obesity",[28,463,465,466,467],"Medicine, Chinese Traditional","Autonomic Nervous System","Randomized Controlled Trial","2026-08-04",{"date":350,"type":43},{"date":471,"type":22},"2026-10-01",{"date":473,"type":22},"2030-10-01",{"name":475,"class":50},"Fohow Pharmaceutical Group",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":489,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":495,"locationsCount":51},"100650990","self-help-booklets-for-sleep-in-adults-with-pulmonary-hypertension-100650990","NCT07754981","Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension","Development and Pilot Randomised Controlled Trial of a Self-help Sleep Hygiene Intervention to Help Individuals With Pulmonary Hypertension","Inclusion Criteria:\n\nParticipants much be aged 18 years and over.\n\nMust have a diagnosis of PH, which they will be asked to self-report i.e. we will not ask for proof.\n\nMust be able to meet the requirements of the study: give informed consent; complete questionnaires; be literate in English.\n\nMust self-report sleep difficulties. This will be asked as a categorical (yes\u002Fno) question rather than captured through an outcome measure. No sleep measure has been validated for this population. Whilst we can measure sleep, we are unable to quantify difficulties and cannot use a more standardised method of determining a clinical cut off for when a participant may be included or excluded from the study.\n\nExclusion Criteria:\n\nParticipants displaying any significant issues of risk such as self-reported thoughts of harm to self or suicidal thoughts will not be eligible for this study. This is because they are unlikely to benefit from a self-help intervention. this will be asked during a screening questionnaire prior to accessing the consent form. Instead, we will signpost this group to relevant services.",{"count":134,"type":22},[25],"The researchers have developed a set of self-help booklets for adults with pulmonary hypertension (PH) who are experiencing sleep problems. The booklets include sleep hygiene advice and are based on a psychological treatment called Cognitive Behavioural Therapy for Insomnia (CBT-I).\n\nCBT-I is a structured, evidence-based treatment for ongoing sleep problems. It helps people understand how their thoughts, behaviours, and daily routines can affect their sleep. It aims to improve sleep quality and help people fall asleep more easily and get back to sleep if they wake during the night.\n\nCBT-I is one of the most effective treatments for ongoing sleep problems. The self-help programme consists of four booklets, which participants will work through at home over four weeks, completing one booklet each week in their own time. The aim of the study is to find out whether the self-help booklets improve sleep quality in people with pulmonary hypertension.\n\nParticipants will be asked to complete questionnaires about their sleep and mental wellbeing, including symptoms of anxiety and depression. Participants will then be randomly allocated to one of two groups. The intervention group will receive the self-help booklets during the study. The wait-list group will receive the booklets at a later date if they are found to be helpful. Having two groups allows the researchers to compare the results and determine whether any improvements in sleep are due to the self-help booklets.\n\nParticipants in the intervention group will also be contacted during the programme to ask about their experiences of using the booklets. Both groups will complete the questionnaires again after four weeks and then again one month later. Participants in the intervention group will also be contacted at the end of the study to discuss their experiences of taking part.",[487,28,488],"Pulmonary Hypertension","Sleep Hygiene",[488,490,491,487,28],"Self-Help","CBT-I",{"date":350,"type":43},{"date":380,"type":22},{"date":263,"type":22},{"name":496,"class":50},"University of Sheffield",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":51},"100649628","chaihushugan-decoction-and-wen-dan-tang-for-insomnia-100649628","NCT07735390","Chaihushugan Decoction and Wen Dan Tang for Insomnia","Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial","Inclusion Criteria:\n\n* Patients aged 20 or older seeking treatment at the Traditional Chinese Medicine outpatient clinic with sleep disorders.\n* Meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders, Third Edition (ICSD-3).\n* Willing to receive traditional Chinese medicine treatment.\n* Able to provide signed informed consent approved by the National Cheng Kung University Hospital Institutional Review Board.\n\nExclusion Criteria:\n\n* Diagnosed with schizophrenia or narcolepsy.\n* History of neurological diseases (e.g., stroke history, neurodegenerative diseases).\n* History of alcohol or drug addiction.\n* Experiencing major, uncontrollable life-altering stressors (e.g., recent bereavement).",{"count":505,"type":22},24,[25],"This study aims to evaluate the clinical effectiveness of Traditional Chinese Medicine (TCM) in treating sleep disorders, specifically chronic insomnia. While conventional TCM treatments often rely heavily on subjective patient feedback, this clinical trial incorporates objective diagnostic tools, including Digital Polysomnography (PSG) and actigraphy, to gather data-driven sleep quality metrics.\n\nParticipants will be randomly assigned to receive either Chaihushugan Decoction or Wen Dan Tang for an 8-week treatment period. Subjective improvements will be tracked using standardized clinical questionnaires such as the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI). The findings from this trial will help clarify the scientific basis and treatment pathways of these two classic herbal formulations for sleep management.",[28,509],"Sleep Wake Disorders",[511],"Chaihushugan Decoction",{"date":419,"type":43},{"date":514,"type":43},"2024-09-13",{"date":516,"type":22},"2029-12-31",{"name":518,"class":50},"Tainan Hospital, Ministry of Health and Welfare",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100650207","study-on-the-management-of-comisa-100650207","NCT07743931","Study on the Management of COMISA","COMISA-PEC","Inclusion Criteria:\n\n* Adult patient diagnosed with COMISA, defined by an apnea-hypopnea index (AHI) ≥ 15 events\u002Fhour and an Insomnia Severity Index (ISI) score ≥ 15, newly diagnosed and naïve to CPAP therapy and daridorexant treatment (no treatment for \\> 5 years).\n* Prescription of continuous positive airway pressure (CPAP) therapy combined with a prescription of daridorexant.\n* Patient has provided informed consent to participate in the study.\n* Patient is affiliated with a national health insurance system.\n\nExclusion Criteria:\n\n* Severe hepatic impairment (contraindication to daridorexant treatment).\n* Refusal of CPAP therapy and\u002For refusal of daridorexant treatment.\n* Individuals covered under Articles L1121-5 to L1121-8 of the French Public Health Code.\n* Staff members who have a hierarchical relationship with the principal investigator.\n* Any patient who, in the opinion of the investigator, would be unable to comply with study procedures or the study schedule.","75 Years",{"count":339,"type":22},[25],"COMISA, the combination of obstructive sleep apnea (OSA) and insomnia, is a frequent and burdensome condition. Many patients with OSA experience clinically significant insomnia symptoms, and a substantial proportion of individuals with chronic insomnia also meet criteria for OSA. This comorbidity is associated with more severe symptoms, more complex diagnostic pathways, and reduced adherence to continuous positive airway pressure (CPAP) therapy. This study aims to better understand COMISA and evaluate whether adding daridorexant to CPAP treatment can improve treatment adherence and overall patient outcomes.",[531,28,532],"Obstructive Sleep Apnea (OSA)","COMISA","2026-07-31",{"date":468,"type":43},{"date":536,"type":22},"2026-08",{"date":538,"type":22},"2029-02",{"name":540,"class":50},"University Hospital, Grenoble",4,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":553,"conditions":554,"keywords":558,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":51},"100614501","evolution-of-insomnia-during-the-first-year-in-patients-newly-diagnosed-with-cancer-100614501","NCT07280416","Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer","Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.","INDICA","Inclusion Criteria:\n\n* Confirmed diagnosis of metastatic or non-metastatic cancer,\n* Cancer treated with intravenous chemotherapy and\u002For immunotherapy administered intravenously or subcutaneously,\n* Age ≥ 18 years,\n* Ability to read and understand French,\n* Patient covered by a social security system,\n* Signed informed consent.\n\nExclusion Criteria:\n\n* SCI questionnaire score \\\u003C16\n* Diagnosed or controlled sleep disorders\n* Presence of severe cognitive disorders (e.g., Alzheimer's disease) or major psychiatric disorders (e.g., psychosis), as noted in the medical record, observed at recruitment, or reported by the patient\n* Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent","80 Years",{"count":552,"type":22},260,"The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms.\n\nThe main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time.\n\nA secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties.\n\nThe study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.",[555,28,97,556,557],"Cancer","Depression Anxiety Disorder","Quality of Life",[559,160,560,561,562],"cancer","pain","Depresion Anxiety disorder","longitudinal",{"date":564,"type":43},"2026-08-03",{"date":566,"type":43},"2025-12-16",{"date":568,"type":22},"2028-11-01",{"name":570,"class":50},"Centre Hospitalier Emile Roux",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":18,"minAge":293,"maxAge":526,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":51},"100617784","40-hz-flickering-for-insomnia-in-parkinsons-disease-100617784","NCT07323121","40 Hz Flickering for Insomnia in Parkinson's Disease","Randomized, Single-blind, Controlled Study of 40 Hz Flickering Stimulation for Insomnia and Other Non-motor Symptoms in Patients With Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to established clinical criteria (e.g., Movement Disorder Society criteria).\n* Age between 50 and 75 years.\n* Disease duration ≤ 10 years and Hoehn and Yahr stage ≤ 3 in the \"on\" state.\n* Clinically significant insomnia, defined as Parkinson's Disease Sleep Scale-2 (PDSS-2) total score ≥ 18 points and\u002For meeting diagnostic criteria for insomnia.\n* Stable antiparkinsonian medication regimen for at least 4 weeks prior to enrollment.\n* Able and willing to comply with study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Secondary insomnia primarily due to severe systemic diseases or major psychiatric disorders (e.g., psychosis, severe depression or anxiety) or substance abuse.\n* History of epilepsy, photosensitive seizures, photosensitive dermatitis, or other conditions in which flicker light stimulation is contraindicated.\n* Severe visual impairment or eye diseases that would interfere with light stimulation or safety assessment.\n* Unstable or severe medical conditions (e.g., uncontrolled cardiovascular, hepatic, renal, or endocrine disease) that, in the investigator's opinion, make participation unsafe.\n* Participation in another interventional clinical trial within the past 3 months.\n* Inability to complete study procedures or follow-up due to cognitive, physical, or social reasons.",{"count":579,"type":22},30,[25],"This randomized, single-blind, controlled clinical trial aims to evaluate the efficacy and safety of 40 Hz flicker light stimulation for insomnia in patients with Parkinson's disease (PD). Patients with PD and clinically significant insomnia will be randomly assigned in a 1:1 ratio to receive either 40 Hz flicker light or control light for 30 minutes every night at bedtime for 7 consecutive days, in addition to standard antiparkinsonian treatment.\n\nThe primary objective is to determine whether 40 Hz flicker light stimulation improves PD-related insomnia as measured by Parkinson's Disease Sleep Scale-2 (PDSS-2). Secondary objectives include evaluating changes in polysomnography-derived sleep parameters, subjective sleep quality, and other non-motor symptoms, as well as assessing the safety and tolerability of the intervention.\n\nThis registration specifically covers the Parkinson's disease insomnia cohort of a larger, previously approved multi-cohort protocol that also includes healthy volunteers and primary insomnia patients.",[583,28],"Parkinson Disease",[585,160,586,587,588],"Parkinson's disease","sleep disorders","40 Hz flickering","gamma oscillation","2026-07-25",{"date":591,"type":43},"2026-07-28",{"date":593,"type":43},"2026-01-01",{"date":595,"type":22},"2026-12-31",{"name":597,"class":50},"Jiangsu Province Nanjing Brain Hospital",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":293,"maxAge":315,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":616,"leadSponsor":617,"locationsCount":51},"100615948","remote-ischemic-conditioning-for-sleep-disturbances-and-other-non-motor-symptoms-in-parkinsons-disease-100615948","NCT07299240","Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease","Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease: a Randomized, Single-blind, Sham-controlled Clinical Study","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.\n* Age between 50 and 70 years.\n* Disease duration ≤ 5 years.\n* Hoehn and Yahr stage I-III in the \"on\" state.\n* Presence of insomnia that meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and clinically significant sleep complaints (for example, Parkinson's Disease Sleep Scale-2 \\[PDSS-2\\] total score ≥ 18 points).\n* On a stable regimen of antiparkinsonian medications for at least 4 weeks prior to enrollment, with no expected dose changes during the study period.\n* Able to understand the study procedures and provide written informed consent (or consent provided by a legally authorized representative when appropriate).\n\nExclusion Criteria:\n\n* Secondary insomnia due to other severe medical conditions (e.g., uncontrolled cardiopulmonary, hepatic, renal, or endocrine diseases).\n* Current psychotic symptoms or severe anxiety or depression (e.g., Hamilton Anxiety Scale score ≥ 14 or Hamilton Depression Scale score ≥ 17).\n* Other primary sleep disorders such as moderate-to-severe obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, or rapid eye movement sleep behavior disorder that require specific treatment.\n* History of significant cerebrovascular disease, brain tumor, central nervous system infection, or other neurological disorders that may interfere with sleep or study assessments.\n* Contraindications to remote ischemic conditioning (RIC), including severe peripheral arterial disease of the upper limbs, local soft tissue infection or damage at the cuff site, subclavian artery thrombosis, malignant hypertension, severe cardiac disease, active bleeding disorders, or other conditions judged unsafe by the investigator.\n* Contraindications to MRI or EEG examinations (e.g., pacemaker, severe claustrophobia, metallic implants incompatible with MRI).\n* Participation in another interventional clinical trial within the past 3 months.\n* Inability to comply with the study procedures or follow-up visits, as judged by the investigator.",{"count":606,"type":22},48,[25],"This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.",[610,28],"Parkinson Disease (PD)",[612,585,160,613],"remote ischemic conditioning","non-motor symptoms",{"date":591,"type":43},{"date":593,"type":43},{"date":595,"type":22},{"name":597,"class":50},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":625,"maxAge":221,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":632,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":641,"leadSponsor":643,"locationsCount":4},"100610693","cognitive-behavioural-therapy-for-insomnia-among-young-people-with-moderate-level-of-mental-distress-in-hong-kong-100610693","NCT07230899","Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong","A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong","Inclusion Criteria:\n\n* JC LevelMind @ Community users at least at risk for mild mental distress (Tier 2), with K6 scores above or equal to 11, or clinicians' endorsement after reviewing the case to have other issues\u002Fproblems\n* Aged between 12 and 24 years\n* Insomnia Severity Index (ISI) score greater than 7\n* Sufficiently proficient in Chinese to comprehend verbal instructions\n* Able to provide written informed consent (parental consent for participant aged 12-17)\n\nExclusion Criteria:\n\n* Young people with mild distress (K6 scores between 0 and 10)\n* Known diagnosis of intellectual disability\n* Organic brain disorder\n* Established psychiatric diagnosis\n* Current substance abuse\n* Receiving other structured psychological therapies such as module-based psychological therapy, mentalization-based therapy, low-intensity online interventions, cognitive-behavioral therapy, narrative therapy, mindfulness, or art-informed therapy within the hub setting or any others outside the hub setting\n* Presence of current or active suicidal ideation or attempts","12 Years",{"count":627,"type":22},160,[25],"This randomized controlled trial (RCT) aims to evaluate the effectiveness of a Cognitive Behavioral Therapy for Insomnia (CBTi) intervention in enhancing sleep quality, overall quality of life, functional ability, and reducing mental distress among at-risk youths in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14.\n\nThe study involves 160 participants who will be randomly assigned to either the intervention group or a wait-list control group. Participants assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers, while those in the control group will receive the same intervention after the initial follow-up period.\n\nParticipants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the CBTi intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation.\n\nIt is hypothesized that youths receiving the CBTi intervention will show significantly greater improvements in sleep quality, quality of life, and functioning, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.",[631,28],"Mental Distress",[633,634,635,636],"cognitive behavioural therapy for insomnia","youths","mental distress","randomised controlled trial","2026-07-24",{"date":639,"type":43},"2026-07-27",{"date":45,"type":22},{"date":642,"type":22},"2027-08-31",{"name":49,"class":50}]