Trial of Diphenhydramine for Sleep in Children With Autism

Phase 2

Recruiting

• Conditions: Autism; Autism Spectrum Disorder
• Interventions: Drug: Diphenhydramine; Drug: Placebo

• Registration Number: NCT05501678
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-15
• Study Start: 2023-08-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diphenhydramine, then Placebo	Diphenhydramine	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.
Diphenhydramine, then Placebo	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.
Placebo, then Diphenhydramine	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.
Placebo, then Diphenhydramine	Placebo	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 Measures

Name	Time	Method
Change from baseline in sleep latency as measured by polysomnography (PSG)	Baseline, Week 4 and Week 8
Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG)	Baseline, Week 4 and Week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy	Baseline, Week 4 and Week 8

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States