[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-disorders-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-disorders-in-children":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639620","phase-3-pediatric-prolonged-release-melatonin-for-sleep-disturbances-in-children-and-adolescents-with-anorexia-nervosa-melsom-anorexia-100639620",false,"NCT07576764","Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)","Efficacy of Pediatric Prolonged-Release Melatonin (PedPRM) Treatment in Children and Adolescents With Impaired Sleep and Anorexia Nervosa (AN)","MELSomAnorexia","INCLUSION CRITERIA\n\nParticipants aged 6 to 18 years, inclusive, with a diagnosis of Anorexia Nervosa (AN) according to DSM-5 criteria Presence of a sleep problem for at least 1 month, defined as ≤ 6 hours of continuous sleep and\u002For ≥ 0.5 hours sleep latency from lights-off on 3 out of 5 nights, based on participant report (with or without parental assistance according to age), confirmed at D0 by 2-week sleep diary No response to at least 4 weeks of sleep hygiene Negative pregnancy test at baseline, prior to randomization, for female participants of childbearing potential Women of childbearing potential must agree to use a highly effective method of contraception during the study treatment period and for at least 4 weeks after the last dose of study treatment Written informed consent obtained in accordance with the participant's legal status and applicable regulations Affiliation to a social security system or equivalent\n\nEXCLUSION CRITERIA\n\nKnown diagnosis of another significant sleep disorder (e.g. moderate to severe sleep apnea) Use of prohibited medication (z-drugs, melatonin agonist, benzodiazepine, phenylpiperazine class, clomethiazole) or melatonin within 2 weeks prior to screening Declared allergy to melatonin, lactose, or any excipient included in the therapeutic units Pregnant or breastfeeding female participants Unresponsiveness to previous prolonged-release melatonin within the 2 years prior to the study Start of cognitive behavioural therapy (CBT) targeting sleep disturbances or mood disorders within 6 weeks before study inclusion Trans-meridian travel (\\> 2 time zones) within the month before the start of the study Patient under legal protection regimen","ALL","6 Years","18 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Many drugs are currently prescribed off-label for their sedative side effects, without proven safety or efficacy in this population.\n\nPediatric prolonged-release melatonin (PedPRM, Slenyto®) is the only melatonin formulation approved by the European Medicines Agency (EMA) for chronic insomnia in children aged 2 to 18 years with neurodevelopmental disorders. Its excellent safety profile, absence of tolerance, and long-acting formulation make it a prime candidate for treating sleep disturbances in children and adolescents with AN.\n\nMELSom-ANOREXIA is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb trial. Its primary objective is to assess the efficacy of PedPRM compared to placebo in improving Total Sleep Time (TST) in children and adolescents aged 6 to 18 years with AN and impaired sleep.\n\nParticipants are randomized into two groups: the experimental group receives PedPRM (2 mg or 5 mg depending on response at Day 22) and the control group receives a matching placebo, both administered 0.5 to 1 hour before habitual bedtime for 13 weeks. Sleep is assessed by Sleep Diary and actigraphy. Secondary outcomes include other sleep parameters, AN severity (BMI, EDI-2, EDE-Q), associated symptoms (anxiety, depression, physical activity, executive function, emotionality), and quality of life. Melatonin secretion profiles and specific subgroups (ASD traits, early-onset AN) are also explored.\n\nThe study includes a 2-week run-in period (D-14 to D0) for baseline sleep assessment, followed by 13 weeks of treatment, with visits at D0, D22, and D93. A total of 120 participants will be enrolled across 7 French pediatric psychiatry centers over 24 months.",[28,29],"Anorexia Nervosa","Sleep Disorders in Children",[31],"anorexia","NOT_YET_RECRUITING","2026-05-04",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":22},"2026-09-01",{"date":40,"type":22},"2029-01-01",{"name":42,"class":43},"Assistance Publique Hopitaux De Marseille","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100407654","melatonin-adolescent-research-study-100407654","NCT04588233","Melatonin Adolescent Research Study","Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)","MARS","Inclusion Criteria:\n\n* Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).\n* Ages 13 to 17 years old\n* Able to understand, read, and write in English\n* Melatonin naive\n\nExclusion Criteria:\n\n* Obesity\n* Use of psychiatric medication\n* Drug(s), or supplements known to affect sleep\n* History of head injury or concussion with loss of consciousness \\>1 minute\n* Daily consumption of \\>1 caffeinated beverage\n* Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)","13 Years","17 Years",{"count":56,"type":22},80,[58],"NA","The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).",[29],[62,63,64,65],"Melatonin","Sleep Disturbance","Adolescents","Daytime Functioning","RECRUITING","2026-01-28",{"date":69,"type":36},"2026-01-30",{"date":71,"type":36},"2021-09-15",{"date":73,"type":22},"2026-05",{"name":75,"class":43},"Loma Linda University",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":44},"100544324","validation-of-pediatric-sleep-questionnaire-on-a-swedish-cohort-100544324","NCT06367400","Validation of Pediatric Sleep Questionnaire on a Swedish Cohort","Validation of Pediatric Sleep Questionnaire, a Multi-center Study in Sweden","Inclusion Criteria:\n\n* Children with OSDB-symptoms referred to ENT-clinics\n* Age between 18 months and 15 years old.\n* Good knowledge of the Swedish language\n\nExclusion Criteria:\n\n* Craniofacial abnormalities\n* Mb Down\n* neuromuscular disorders\n* do not understand swedish","18 Months","15 Years",{"count":87,"type":22},520,"OBSERVATIONAL","This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.",[91,92,29,93],"Obstructive Sleep Apnea","Sleep Disorder","Obstructive Sleep Apnea of Child",[95,96,97],"OSDB","PSQ","Pediatrics","2024-04-11",{"date":100,"type":36},"2024-04-16",{"date":102,"type":36},"2024-03-01",{"date":104,"type":22},"2034-12-31",{"name":106,"class":43},"Uppsala University"]