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Study details
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Diphenhydramine for Sleep in Children with Autism

Stanford University
NCT IDNCT05501678ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

26

Study length

about 4.4 years

Ages

8–17

Locations

1 site in CA

About this study

Researchers are testing if diphenhydramine helps children with autism sleep better. The trial will use a double-blind, placebo-controlled method to see how diphenhydramine affects sleep patterns and clinical measures over 8 weeks.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Diphenhydramine
  • 2.Take Placebo
PhasePhase 2
DrugDiphenhydramine
Primary goalChange from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low7%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

diphenhydramine

Endpoints

Primary: Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG), Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy

Secondary: Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy

Body systems

Psychiatry / Mental Health