Using diphenhydramine to improve sleep in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of diphenhydramine, an antihistamine with sedative properties, on sleep in children and adolescents diagnosed with Autism Spectrum Disorder (ASD). It employs a randomized double-blind placebo-controlled crossover design over 8 weeks, utilizing polysomnography and actigraphy to assess sleep physiology and disturbances. Participants will be monitored for changes in sleep patterns and overall sleep quality, providing valuable data on the efficacy of diphenhydramine for this population.

Why it matters

Who can join: the full rules

Inclusion criteria:

Participants will meet the following

* Outpatients between 8 and 17 years of age at the time of consent
* Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2).
* Males and females
* Availability of polysomnography (PSG) or actigraphy data
* Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher
* care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
* stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
* no planned changes in psychosocial and biomedical interventions during the trial
* willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial).

Exclusion criteria:

Participants will be excluded if one or more of the following is met

* active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
* active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology)
* evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis
* pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
* individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder/epilepsy, melatonin and centrally-acting antihistamines
* history of hypersensitivity to diphenhydramine
* history of severe side effects from diphenhydramine
* history of adequate trial of diphenhydramine
* current use of any medications known to interact with diphenhydramine such as medications inhibiting CYP2D6
* taking anticholinergic agents (e.g., trihexyphenidyl, thioridazine).

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Antonio Y. Hardan, MD — Stanford University
• Study coordinator: Ryan Villacrucis
• Email: acesleepstudy@stanford.edu
• Phone: (650)736-1235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.