Trial of Zolpidem for Sleep in Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540574
• Other study ID #: IRB-67221
• Secondary ID: 1P50HD109861
• Status: Recruiting
• Phase: Phase 2
• Start date: August 9, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: Emma Baker, PhD
• Phone: (650) 736-1235
• Email: acesleepstudy[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion criteria:

Participants will meet the following

• Outpatients between 8 and 17 years of age with only 12 to 17 years of age 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)

• Males and females

• Availability of polysomnography (PSG) and actigraphy data

• Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 80% or less

• 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 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).

Exclusion criteria:

Participants will be excluded if one or more of the following is met

• active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder

• active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), and hepatic insufficiency

• evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), 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 and chromosomal analysis

• pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)

• individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin, antihistamines and antidepressants

• 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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Drug:
• Zolpidem
5mg (and up to10mg) Diphenhydramine given orally
• Placebo
Matching Placebo given orally

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale score		Baseline, Week 4 and Week 8
Other	Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Parent Sleep Habits Questionnaire Parent (PSHQ) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Clinical Global Impression Scale (CGI) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Child Behavior Checklist (CBCL) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Social Responsiveness Scale, Second Edition (SRS-2) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Repetitive Behavior Scale - Revised (RBS-R) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Sensory Profile Questionnaire (SPQ) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Stanford Social Dimension Scale (SSDS) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on Dimensional Assessment of Repetitive Behaviors (DARB) scores		Baseline, Week 4 and Week 8
Other	Change from baseline on NEuroPSYchological Assessment, 2nd Edition (NEPSY-2) Affect Recognition scores		Baseline, Week 4 and Week 8
Primary	Change from baseline in sleep architecture as measured by polysomnography (PSG), examples include sleep latency and non-rapid eye movement (NREM)		Baseline, Week 4 and Week 8
Secondary	Change from baseline in sleep efficiency as measured by actigraphy		Baseline, Week 4 and Week 8