RecruitingPhase 2NCT05546554

Trial of Suvorexant for Sleep in Children With Autism

Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism


Sponsor

Stanford University

Enrollment

26 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.


Eligibility

Min Age: 13 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a medication called suvorexant (a sleep aid that works by blocking signals that keep the brain awake) can improve sleep in teenagers with autism spectrum disorder (ASD) who have significant sleep problems. Sleep difficulties are very common in autistic youth and can worsen behavior, learning, and quality of life. This trial aims to see if suvorexant is safe and effective for this group. You may be eligible if: - Your child is between 13 and 17 years old - Your child has a confirmed diagnosis of autism spectrum disorder (ASD) - Your child has significant sleep problems (difficulty falling asleep, staying asleep, or getting enough sleep) - Your child's medications have been stable for at least 2 weeks You may NOT be eligible if: - Your child has active suicidal thoughts or a diagnosis of severe depression, substance use disorder, schizophrenia, or psychosis - Your child has unstable medical conditions like epilepsy, severe asthma, obstructive sleep apnea, or serious liver or heart disease - Your child is pregnant or sexually active without reliable contraception - Your child has a history of narcolepsy or known hypersensitivity to suvorexant - Your child currently takes benzodiazepines, certain antiepileptic drugs for seizures, melatonin, or antihistamines for sleep Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSuvorexant

5 mg (and up to 20 mg) Suvorexant given orally

DRUGPlacebo

Matching Placebo given orally


Locations(1)

Stanford University

Stanford, California, United States

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NCT05546554


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