RecruitingPhase 2NCT05501678

Trial of Diphenhydramine for Sleep in Children With Autism

Randomized Placebo-controlled Crossover Trial of Diphenhydramine for Sleep in Children With Autism


Sponsor

Stanford University

Enrollment

26 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether diphenhydramine (commonly known as Benadryl) can help improve sleep in children and teenagers with autism spectrum disorder (ASD) who also have sleep problems. You may be eligible if: - Your child is between 8 and 17 years old - Your child has an ASD diagnosis confirmed by standard assessments - Your child has sleep problems (CSHQ score of 41 or higher) - Medications have been stable for at least 2 weeks (or 4 weeks for Prozac) - You are able to bring your child to all clinic visits reliably You may NOT be eligible if: - Your child has active suicidal thoughts or a diagnosis of schizophrenia or psychosis - Your child has asthma, migraines, active seizures, or significant liver, kidney, or heart problems - Your child is pregnant or sexually active without reliable contraception - Your child is taking benzodiazepines, antiepileptic medications for seizures, melatonin, or antihistamines - Your child has a history of allergy or severe side effects from diphenhydramine - Your child is taking anticholinergic medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDiphenhydramine

25mg (and up to 50mg) Diphenhydramine given orally

DRUGPlacebo

Matching Placebo given orally


Locations(1)

Stanford University

Stanford, California, United States

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NCT05501678


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