[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"delayed-sleep-wake-phase-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:delayed-sleep-wake-phase-disorder":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,69,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100589071","pupillometry-in-delayed-sleep-wake-phase-disorder-100589071",false,"NCT06949644","Pupillometry in Delayed Sleep Wake Phase Disorder","Pupillometry in DSWPD Type 1 and Type 2","Inclusion Criteria:\n\n* Delayed sleep-wake phase disorder\n\nExclusion Criteria:\n\n* Use of medications known to alter pupil diameter\n* History of eye disease or eye surgery\n* Unstable medical or psychiatric condition\n* Shift work or self imposed irregular sleep schedules\n* Caffeine consumption \\>400mg\u002Fday","ALL","16 Years",{"count":19,"type":20},220,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this observational study is to characterize the pupil light response in patients with delayed sleep-wake phase disorder. A subset of participants will take part in a clinical trial to determine if increasing serotonin can alter the circadian response to light. The main questions it aims to answer is:\n\nAre there differences in the light response in patients with delayed sleep-wake phase disorder? Does citalopram increase melatonin suppression in patients with delayed sleep-wake phase disorder?\n\nParticipants will complete activity and melatonin testing at home to determine their circadian timing. This will be followed by an eye test looking at the pupil response to different light stimuli. A subset of participants will complete two inpatient admissions where melatonin levels will be sampled and they will be exposed to a bright light. During one round of testing they will receive a placebo and in the other round of testing they will take a single dose of citalopram, a selective serotonin reuptake inhibitor.",[26],"Delayed Sleep-Wake Phase Disorder","RECRUITING","2026-06-04",{"date":30,"type":31},"2026-06-08","ACTUAL",{"date":33,"type":31},"2025-09-01",{"date":35,"type":20},"2029-08-31",{"name":37,"class":38},"Northwestern University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":39},"100533454","phase-2-correcting-circadian-rhythms-to-breakthrough-in-bipolar-disorder-100533454","NCT06226025","Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for bipolar disorder (BD) I or II\n* Evening chronotype per the Morningness-Eveningness Questionnaire (MEQ) defined by a score of \\\u003C42\n* At least mild depressive symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5\n* Psychotropic medications at stable dose for past month\n* Able to download the MyDataHelps mobile application (app), and open app on participants' own phone\n* Willing to abstain from alcohol for the duration of the intervention phase\n* Female participants of childbearing potential (i.e., patients are not permanently sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or postmenopausal (12 months with no menses without an alternative medical cause) by report) must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.\n\nExclusion Criteria:\n\n* Current diagnosis of, or high risk for, a sleep disorder other than DSPD per interview and medical record review (when available) including:\n\n  * Insomnia per DSM-5\n  * Sleep-disordered breathing per Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP-BANG)\n  * Restless leg syndrome per sleep interview\n  * Narcolepsy\n  * Suspicion of vasomotor symptoms impacting sleep per interview for women that may be perimenopausal or postmenopausal.\n* Risk of current mania (per Young Mania Rating Scale (YMRS) score \\> 19).\n* Suicidal or at high risk for suicide per Columbia Suicide Severity Rating Scale (C-SSRS) guidelines (i.e., presence of any suicidal behavior-suicide attempt, interrupted attempt, abort attempt, or preparatory behavior-in the past 3 months; and\u002For current active suicidal ideation with any intent), or as determined by the principal investigators.\n* Presence of cardiac implantable electronic device, such as defibrillator or pacemaker.\n* Presence of chronic psychiatric conditions which may directly influence sleep per interview and medical record review (when available), including:\n\n  * Current illicit drug use per the Drug Use Disorders Identification Test (DUDIT) defined by a score of ≥ 25\n  * Current alcohol or drug abuse per the Alcohol Use Disorder Identification Test (AUDIT) defined by a score of ≥ 16 and DUDIT\n  * Currently experiencing psychosis\n* Presence of unstable chronic medical condition which may directly influence sleep:\n\n  * Chronic pain\n  * Thyroid conditions\n* Current or history of medical conditions which may be affected by melatonin per self-report and medical record review (when available), such as:\n\n  * Hypertension or hypotension\n  * Diabetes Type 1 or Type 2\n  * Clotting\u002Fbleeding disorders\n  * Epilepsy\u002Fseizures\n  * Autoimmune disorders\n  * Conditions requiring immunosuppressive management such as transplant\n* Per self-report or medical record review (when available), current use of medications which may have interactions with melatonin (see protocol for more details).\n* Current use of medications that may interfere with the measurement of melatonin (non-steroidal anti-inflammatory drugs if used daily, and beta-blockers), per self-report and medical record review (when available).\n* Self-report use of melatonin in the past month.\n* Hypersensitivity to melatonin or any other component of the melatonin or placebo product.\n* Pregnancy (as determined by dipstick urinary pregnancy test at screening for women of child-bearing potential) or self-report of breastfeeding and\u002For plan to become pregnant in the next 3 months.\n* Self-report of routine night shift work.\n* Self-report of past month travel or planned travel during the study across more than one time zone.","18 Years","60 Years",{"count":49,"type":20},50,[51],"PHASE2","The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo.\n\nThe hypotheses for this study include:\n\n* Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment.\n* Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.",[54,26],"Bipolar Disorder",[56,57,58,59],"Correcting Circadian Rhythms","Melatonin","Placebo","Dim light melatonin onset","2026-05-07",{"date":62,"type":31},"2026-05-11",{"date":64,"type":31},"2024-08-13",{"date":66,"type":20},"2026-12",{"name":68,"class":38},"Leslie Swanson",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100452864","sleep-in-psychiatric-care-sip-treatment-for-comorbid-delayed-sleep-wake-phase-disorder-dswpd-100452864","NCT05177055","Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)","Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)","SIP","Inclusion Criteria:\n\n* Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital\n* Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for DSWPD comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to DSWPD and\u002For scores of ≥19 on BDI and\u002For scores of ≥16 on BAI at the time of referral to the sleep school)\n\nExclusion Criteria:\n\n* Night work\n* Patients that do not fulfil the DSM-V criteria for DSWPD comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and\u002For scores of ≥19 on BDI and\u002For scores of ≥16 on BAI at the time of referral to the sleep school)","80 Years",{"count":79,"type":20},60,[23],"Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and\u002For melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.",[26,83,84],"Sleep Disorder","Psychiatric Disorder",[86,87,88,89,90],"Sleep disorders","Delayed sleep-wake phase disorder","blue-blocking glasses","psychiatric disorders","group-based treatment for circadian rhythm sleep disorder","2024-06-07",{"date":93,"type":31},"2024-06-11",{"date":95,"type":31},"2022-05-23",{"date":97,"type":20},"2027-12-31",{"name":99,"class":38},"Haukeland University Hospital",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":46,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":100},"100547383","promoting-sleep-and-physical-activity-among-adolescent-psychiatric-patients-100547383","NCT06407258","Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients","Transdiagnostic Sleep Intervention Combined With Physical Activity Counseling (SLEEPAC) in Adolescent Psychiatric Patients: A Blended Care Approach","SLEEPAC","Inclusion Criteria:\n\n* Aged between 13 to 18 years\n* Presence of insomnia and\u002For delayed sleep-wake phase disorder\n* At least one further diagnosis of DSM-5\n* Written informed consent of parents \u002F primary caregiver\n\nExclusion Criteria:\n\n* Organic sleep- and brain disorders (i.e., obstructive sleep apnea, narcolepsy, epilepsy)\n* Suffering from medical conditions, which prevent participation in physical activity\n* Changes to medication regime during the study protocol\n* Color-blindness (due to stroop test)","13 Years",{"count":111,"type":20},140,[23],"Mental health disorders pose a significant burden on adolescent populations globally, often accompanied by sleep disturbances. Emerging evidence suggests that addressing sleep issues can improve mental health outcomes, while physical activity is increasingly recognized as beneficial for both sleep and mental well-being. This study aims to assess the effectiveness of a novel intervention (SLEEPAC), combining cognitive-behavioral therapy for insomnia (CBT-I), circadian treatment, and PA counseling, compared to treatment as usual (TAU), in improving psychopathology among adolescent psychiatric outpatients with sleep disturbances. Secondary outcomes include improvements in sleep health, physical activity levels, cognitive performance and self-esteem. Additionally, the study seeks to explore the predictive value of sleep neurophysiological biomarkers using high-density sleep electroencephalography (EEG), contributing to advancements in precision psychiatry for this population.",[115,116,26],"Mental Disorder in Adolescence","Insomnia",[118,119,120,121,122,123],"adolescents","CBT-I","light therapy","circadian adaptation","physical activity counseling","transdiagnostic","NOT_YET_RECRUITING","2024-05-06",{"date":127,"type":31},"2024-05-09",{"date":129,"type":20},"2024-06-01",{"date":131,"type":20},"2026-06-30",{"name":133,"class":38},"Christin Lang"]