Using suvorexant to improve sleep in children with autism
Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism
PHASE2 · Stanford University · NCT05546554
This study is testing if a sleep medication called suvorexant can help children and teens with autism sleep better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05546554 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of suvorexant, a medication that helps with sleep onset and maintenance, in children and adolescents diagnosed with Autism Spectrum Disorder (ASD). It employs a randomized double-blind placebo-controlled crossover design over 8 weeks to assess sleep physiology through polysomnography, actigraphy, and clinical measures. Participants will be monitored for sleep disturbances and overall sleep quality to determine the efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 13 to 17 with a confirmed diagnosis of Autism Spectrum Disorder and significant sleep disturbances.
Not a fit: Patients without sleep disturbances or those not meeting the age and diagnostic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality in children with autism, enhancing their overall well-being and daily functioning.
How similar studies have performed: Other studies have explored sleep interventions in autism, but the specific use of suvorexant in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Participants will meet the following * Outpatients between 13 and 17 years of age at 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) and/or actigraphy data * Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time less than 7 hours and/or wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy * 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). * requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms). Exclusion criteria: Participants will be excluded if one or more of the following is met * active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder * unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), obstructive sleep apnea and severe hepatic insufficiency * 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 * pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study) * Benzodiazepines, antiepileptic medications when prescribe for seizure disorder/epilepsy, melatonin and centrally-acting antihistamines * history of hypersensitivity to suvorexant * history of severe side effects from suvorexant * history of adequate trial of suvorexant * current use of any medications known to interact with suvorexant such as medications inhibiting CYP3A * history of narcolepsy
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.
Conditions: Autism, Autism Spectrum Disorder, Suvorexant, Sleep, clinical trial, autism