drugset / Trial / NCT05501678

Trial of Diphenhydramine for Sleep in Children With Autism

NCT05501678

RandomizedCrossoverQuadruple-blindBasic science

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.

Timeline

Start
2023-08-09
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Diphenhydramine Unknown 50 mg Oral

Indications