Trial of Diphenhydramine for Sleep in Children With Autism

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05501678
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Diphenhydramine — DRUG
    25mg (and up to 50mg) Diphenhydramine given orally
  • Placebo — DRUG
    Matching Placebo given orally

Study Details

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.

Key Dates

Start date
Aug 9, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Diphenhydramine, then Placebo
    Participants will first receive Diphenhydramine for a 4-week period. A 25 mg dose of Diphenhydramine will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated. Participants will then receive Placebo (fake tablet) for a 4-week period. A 25 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated.
  • Experimental: Placebo, then Diphenhydramine
    Participants will first receive Placebo (fake tablet) for a 4-week period. A 25 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated. Participants will then receive Diphenhydramine for a 4-week period. A 25 mg dose of Diphenhydramine will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated.

Primary Outcome Measure

Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy [ Time Frame: Baseline, Week 4 and Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-5719
Ryan Villacrucis
[email protected]
(650) 736-1235
Robin Libove
[email protected]
(650) 736-1235
Antonio Y. Hardan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Stanford University· Stanford, CA

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