Diphenhydramine for Sleep in Children with Autism
Phase 2
26
about 4.4 years
8–17
1 site in CA
What this study is about
Researchers are testing if diphenhydramine helps children with autism sleep better. The trial will use a double-blind, placebo-controlled method to see how diphenhydramine affects sleep patterns and clinical measures over 8 weeks.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Diphenhydramine
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
diphenhydramine
Primary: Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG), Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy
Secondary: Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy
Psychiatry / Mental Health