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NCT05501678 · ClinicalTrials.gov registry record · Phase 2
Trial of Diphenhydramine for Sleep in Children With Autism
A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05501678: Recruiting Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Stanford University.
NCT05501678 is a Phase 2 study of Autism Spectrum Disorder and Autism that is actively recruiting participants, run by Stanford University. The registered enrollment target is 26 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05501678, a Phase 2 study of Autism Spectrum Disorder and Autism, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Diphenhydramine
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-08-09 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT05501678 shows while recruiting
NCT05501678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05501678 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05501678 about?
NCT05501678 is a clinical study titled "Trial of Diphenhydramine for Sleep in Children With Autism". 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 pla...
What is the current status of trial NCT05501678?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-08-09. Estimated completion is 2027-12-31.
What conditions does trial NCT05501678 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
What interventions are being tested in trial NCT05501678?
The interventions under investigation include: Placebo (DRUG), Diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT05501678?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05501678 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05501678's enrollment target sits among peer trials
26 178th of 224 higher than 43 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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