Randomized Placebo-controlled Crossover Trial of Diphenhydramine for Sleep in Children With Autism

Stanford University

Summary

The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Eligibility

Age range: 8–17 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion criteria: Participants will meet the following * Outpatients between 8 and 17 years of age at the time of consent * 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) or actigraphy data * Sleep disturbances as assessed using Children's Sleep Habits Ques…

Interventions

Drug
Diphenhydramine
25mg (and up to 50mg) Diphenhydramine given orally
Drug
Placebo
Matching Placebo given orally

Location

Stanford University
Stanford, California
acesleepstudy@stanford.edu (650) 736-1235

Randomized Placebo-controlled Crossover Trial of Diphenhydramine for Sleep in Children With Autism

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions