Using diphenhydramine to improve sleep in children with autism
Randomized Placebo-controlled Crossover Trial of Diphenhydramine for Sleep in Children With Autism
This study is testing if diphenhydramine can help improve sleep for children and teens with autism.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05501678 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 8 to 17 with a confirmed diagnosis of Autism Spectrum Disorder and significant sleep disturbances.
Not a fit: Patients without sleep disturbances or those who do not meet the diagnostic criteria for Autism Spectrum Disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality for children with autism, enhancing their overall well-being and daily functioning.
How similar studies have performed: While there have been studies on sleep interventions in children with autism, the specific use of diphenhydramine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.