[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05540574":3,"trial-entities:NCT05540574":113,"trial-summary:NCT05540574":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":47,"secondary_outcomes":51,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":83,"locations":85,"central_contacts":106,"overall_officials":109,"references":111,"see_also_links":112},"NCT05540574","IRB-67221","Trial of Zolpidem for Sleep in Children With Autism","Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism","RECRUITING","2028-04-30","2026-03","2026-03-27","2023-08-09","Stanford University","OTHER",true,"The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.",null,[19,20],"Autism","Autism Spectrum Disorder",[22,23,24,25],"zolpidem","sleep","clinical trial","autism","INTERVENTIONAL","BASIC_SCIENCE",[29],"PHASE2",{"count":31,"type":32},26,"ESTIMATED",[34,43],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":41},"DRUG","Zolpidem","5mg (and up to10mg) Diphenhydramine given orally",[39,40],"Placebo, then Zolpidem","Zolpidem, then Placebo",[42],"Ambien",{"type":35,"name":44,"description":45,"armGroupLabels":46},"Placebo","Matching Placebo given orally",[39,40],[48],{"measure":49,"timeFrame":50},"Change from baseline in sleep architecture as measured by polysomnography (PSG) and\u002For actigraphy, examples include sleep latency and non-rapid eye movement (NREM)","Baseline, Week 4 and Week 8",[52],{"measure":53,"timeFrame":50},"Change from baseline in sleep efficiency as measured by actigraphy","ALL","8 Years","17 Years",false,{"inclusion":59,"exclusion":70,"raw_text":82},[60,61,62,63,64,65,66,67,68,69],"Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1","Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2)","Males and females","Availability of polysomnography (PSG) and\u002For actigraphy data","Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and\u002For total sleep time less than 7 hours and\u002For wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy.","care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis","stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks","no planned changes in psychosocial and biomedical interventions during the trial","willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial)","requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).",[71,72,73,74,75,76,77,78,79,80,81],"active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder","unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology) and hepatic insufficiency","evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism;","pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)","individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder\u002Fepilepsy, antidepressants, melatonin and centrally-acting antihistamines","history of hypersensitivity to zolpidem","history of severe side effects from zolpidem","history of adequate trial of zolpidem","current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2","history of complex sleep-related behaviors","individuals using alcohol, marijuana and other substances.","Inclusion criteria:\n\nParticipants will meet the following\n\n* Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1\n* Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2)\n* Males and females\n* Availability of polysomnography (PSG) and\u002For actigraphy data\n* Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and\u002For total sleep time less than 7 hours and\u002For wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy.\n* care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis\n* stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks\n* no planned changes in psychosocial and biomedical interventions during the trial\n* willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial)\n* requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).\n\nExclusion criteria:\n\nParticipants will be excluded if one or more of the following is met\n\n* active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder\n* unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology) and hepatic insufficiency\n* evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism;\n* pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)\n* individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder\u002Fepilepsy, antidepressants, melatonin and centrally-acting antihistamines\n* history of hypersensitivity to zolpidem\n* history of severe side effects from zolpidem\n* history of adequate trial of zolpidem\n* current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2\n* history of complex sleep-related behaviors\n* individuals using alcohol, marijuana and other substances.",[84],"CHILD",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":103},"Stanford","California","94305-5719","United States",[92,97,100],{"name":93,"role":94,"phone":95,"email":96},"Ryan Villacrucis","CONTACT","(650) 736-1235","acesleepstudy@stanford.edu",{"name":98,"role":94,"phone":95,"email":99},"Robin Libove, BS","rlibove@stanford.edu",{"name":101,"role":102},"Antonio Y. Hardan, MD","PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},37.42411,-122.16608,[107,108],{"name":93,"role":94,"phone":95,"email":96},{"name":98,"role":94,"phone":95,"email":99},[110],{"name":101,"affiliation":13,"role":102},[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[20],[],{"nct_id":4,"found":15,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is a randomized, double-blind, placebo-controlled crossover study involving 26 participants. This means participants will receive either zolpidem or a placebo, and neither they nor the researchers will know which they are getting.","completed","Zolpidem for Sleep in Children and Adolescents with Autism","This study is looking at how zolpidem, a medication used for sleep, affects sleep in children and adolescents (ages 8 to 17) who have Autism Spectrum Disorder (ASD). Researchers want to see if zolpidem can improve sleep patterns. They will compare zolpidem to a placebo (an inactive substance) over 8 weeks. Success will be measured by changes in sleep patterns, such as how long it takes to fall asleep and different stages of sleep, using special tests like polysomnography (PSG) and actigraphy. The study plans to enroll 26 participants, but its current recruitment status is unclear.","Participants will be followed for 8 weeks, with sleep measurements taken at baseline, Week 4, and Week 8.",96,"Participants will have their sleep architecture measured at the beginning of the study, at Week 4, and at Week 8. This involves tests like polysomnography (PSG) and actigraphy.","Not stated in the trial record.",[36,44],"v2"]