Clin2
NCT05501678Possibly a fitRecruiting

Diphenhydramine to help sleep in autistic children

AutismAutism Spectrum Disorder

Treatments studied

Part of Mental health clinical trials.

This Phase 2 study tests whether diphenhydramine improves sleep in children with autism who have significant sleep problems. It requires sleep monitoring (watch data and sleep testing) and checking for side effects to see if the treatment is safe and helpful.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
26 people
Ages
8 years to 17 years
Study type
Interventional

Who can take part

  • Your child is 8 to 17 years old and lives with a caregiver who can bring them to visits
  • Your child has a confirmed autism diagnosis (based on specialist evaluation and specific autism assessments)
  • Your child has sleep problems, with a screening score of 41 or higher on a sleep questionnaire
  • Your child can do sleep tracking, including sleep study testing and wearing an activity watch
  • Your child’s medications are stable: most must be unchanged for at least 2 weeks (and Prozac for 4 weeks)
  • You can follow the plan for the whole study, including no major changes in behavioral/medical supports during the trial

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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