[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Christoph Nissen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100575042","comparative-efficacy-of-brt-and-cbt-i-for-insomnia-100575042",false,"NCT06767137","Comparative Efficacy of BRT and CBT-I for Insomnia","Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial","SLEEPwindow","Inclusion Criteria:\n\n* Must meet DSM-5 criteria for insomnia disorder.\n* Adults aged 18 to 80 years\n* Capable of giving written informed consent.\n* Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.\n\nExclusion Criteria:\n\n* Unstable, progressive, or degenerative medical condition\n* Acute pain or poorly managed chronic pain\n* Suicidality\n* Uncontrolled psychiatric condition requiring treatment outside of study\n* Alcohol or drug abuse or dependency\n* Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder\n* Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)\n* Evidence of intellectual disability\n* Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)\n* Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)\n* Current other psychotherapy for insomnia\n* Known pregnancy or breastfeeding\n* Inability to comply with study procedure\n* Insufficient fluency in German or French to complete the study","ALL","18 Years","80 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.",[28,29,30,31,32,33,34],"Insomnia Disorders","Insomnia Disorder","Insomnia","Insomnia Chronic","Insomnia, Primary","Insomnia, Nonorganic","Insomnia Type; Sleep Disorder",[36,37,38,39],"insomnia","cognitive behavioral therapy","bedtime restriction","sleep restriction","RECRUITING","2025-02-13",{"date":43,"type":44},"2025-02-17","ACTUAL",{"date":46,"type":22},"2025-03-10",{"date":48,"type":22},"2027-11-01",{"name":50,"class":51},"Christoph Nissen","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100550141","sleep-modulation-to-treat-depression-100550141","NCT06443216","Sleep Modulation to Treat Depression","Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder","Inclusion Criteria:\n\n* Written informed consent\n* MDD according to ICD-10 criteria (F32.1\u002F2, F33.1\u002F2; i.e. unipolar depression) for patient group\n\nExclusion Criteria:\n\n* Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders\n* Known pregnancy\n* Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.\n* Relevant neurological disorders, including epilepsy, stroke, etc.\n* Organic sleep disorders including relevant sleep apnea (AHI\\>15\u002Fh), periodic limb movement disorder (PLMS index\\>5\u002Fh), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work\u002F jet lag\n* Intake of medication affecting the central nervous system (other than antidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included\n* Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS or deep brain stimulation\n* Contraindications for tDCS or TMS studies, including but not limited to metal in the head\u002F brain or epilepsy\n* Hearing impairment or tinnitus (auditory stimulation study)\n* Inability to follow the procedures of the study (for example due to language problems)\n* Left-handedness",true,"30 Years","60 Years",{"count":63,"type":22},60,[25],"Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.",[67,68],"Major Depressive Disorder","Healthy","2024-07-22",{"date":71,"type":44},"2024-07-23",{"date":69,"type":44},{"date":74,"type":22},"2026-07",{"name":50,"class":51},1,""]