Actively Recruiting
Trial of Diphenhydramine for Sleep in Children With Autism
Led by Stanford University · Updated on 2026-03-27
26
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Trial of Diphenhydramine for Sleep in Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients between 8 and 17 years of age at the time of consent
- Diagnosis of Autism Spectrum Disorder confirmed by clinical evaluation and standardized assessments (ADI-R, ADOS-2, or CARS-2)
- Male or female participants
- Availability of polysomnography (PSG) or actigraphy data
- Sleep disturbances with Children's Sleep Habits Questionnaire (CSHQ) score of 41 or higher
- Care provider able to reliably bring participant to clinic visits, provide trustworthy ratings, and interact regularly
- Stable medications for at least 2 weeks, except Prozac which must be stable for at least 4 weeks
- No planned changes in psychosocial or biomedical treatments during the trial
- Willingness to provide saliva samples and participate in key study procedures including safety assessments, PSG at weeks 4 and 8, and wearing the actigraphy watch before and during the trial
You will not qualify if you...
- Active suicidal ideation or diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
- Active medical problems including migraine, asthma, seizure disorder, or serious physical illness
- Evidence of metabolic or infectious causes for autism based on medical and neurologic history and tests
- Pregnant or sexually active females not using reliable contraception
- Use of benzodiazepines, antiepileptic medications for seizure disorder, melatonin, or centrally-acting antihistamines
- History of hypersensitivity or severe side effects from diphenhydramine
- History of adequate trial of diphenhydramine
- Current use of medications that interact with diphenhydramine such as CYP2D6 inhibitors
- Use of anticholinergic agents like trihexyphenidyl or thioridazine
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305-5719
Actively Recruiting
Research Team
R
Ryan Villacrucis
CONTACT
R
Robin Libove
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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