RECRUITING

Trial of Zolpidem for Sleep in Children with Autism

Conditions

Autism Autism Spectrum Disorder zolpidem sleep clinical trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Official Title

Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children with Autism

Quick Facts

Study Start:2023-08-09

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05540574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1 * 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) * Males and females * Availability of polysomnography (PSG) and actigraphy data * Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 80% or less * 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 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).	* 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), and hepatic insufficiency * evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), 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 beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin, antihistamines and antidepressants * history of hypersensitivity to zolpidem * history of severe side effects from zolpidem * history of adequate trial of zolpidem * current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2 * history of complex sleep-related behaviors * individuals using alcohol, marijuana and other substances.

Inclusion Criteria

Exclusion Criteria

* Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1
* 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)
* Males and females
* Availability of polysomnography (PSG) and actigraphy data
* Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 80% or less
* 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 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).

* 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), and hepatic insufficiency
* evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), 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 beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin, antihistamines and antidepressants
* history of hypersensitivity to zolpidem
* history of severe side effects from zolpidem
* history of adequate trial of zolpidem
* current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2
* history of complex sleep-related behaviors
* individuals using alcohol, marijuana and other substances.

Contacts and Locations

Study Contact

Emma Baker, PhD

CONTACT

(650) 736-1235

acesleepstudy@stanford.edu

Robin Libove, BS

CONTACT

(650) 736-1235

rlibove@stanford.edu

Principal Investigator

Antonio Y. Hardan, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Stanford, California, 94305-5719

United States

Collaborators and Investigators

Sponsor: Stanford University

Antonio Y. Hardan, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-09

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2023-08-09

Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

zolpidem
sleep
clinical trial
autism

Additional Relevant MeSH Terms

Autism
Autism Spectrum Disorder