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Zolpidem for Sleep Disturbances in Children with Autism

Phase 2
Recruiting
Led By Antonio Y. Hardan, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 and week 8
Awards & highlights

Study Summary

This trial is studying how a drug (zolpidem) affects sleep in kids and teens with autism, using techniques like polysomnography and actigraphy.

Who is the study for?
This trial is for children and adolescents aged 8-17 with Autism Spectrum Disorder who have sleep disturbances. They must not be on certain medications, have stable medication use for the past 4 weeks, and meet specific autism diagnostic criteria. Sexually active females must use dual contraception.Check my eligibility
What is being tested?
The study tests Zolpidem's effect on sleep in kids with ASD using a double-blind method where neither doctors nor participants know who gets Zolpidem or placebo. It involves sleep studies, wearing an activity watch, and no changes in treatments during the trial.See study design
What are the potential side effects?
Zolpidem may cause side effects like daytime drowsiness, dizziness, headaches, gastrointestinal issues (nausea), allergic reactions or complex sleep-related behaviors such as sleepwalking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Polysomnography
Secondary outcome measures
Actigraphy
Other outcome measures
Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores
Change from baseline on Child Behavior Checklist (CBCL) scores
Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale score
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Zolpidem, then PlaceboExperimental Treatment2 Interventions
Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Group II: Placebo, then ZolpidemExperimental Treatment2 Interventions
Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zolpidem
2003
Completed Phase 4
~2530
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,324 Total Patients Enrolled
33 Trials studying Autism Spectrum Disorder
4,071 Patients Enrolled for Autism Spectrum Disorder
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,824 Total Patients Enrolled
20 Trials studying Autism Spectrum Disorder
2,420 Patients Enrolled for Autism Spectrum Disorder
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
8 Previous Clinical Trials
425 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
377 Patients Enrolled for Autism Spectrum Disorder

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05540574 — Phase 2
Autism Spectrum Disorder Research Study Groups: Zolpidem, then Placebo, Placebo, then Zolpidem
Autism Spectrum Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05540574 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540574 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age-restriction for enrollment in this research experiment?

"This research study allows for volunteers between the ages of 8 and 17, in accordance with its eligibility requirements."

Answered by AI

Has Zolpidem been given the green light by the FDA?

"Our assessment of Zolpidem's safety falls at a 2 as there is limited evidence indicating its efficacy, though much more exists in regards to the drug's security."

Answered by AI

Could you provide an estimate of the people enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov data shows that this medical inquiry, which was first posted on July 12th 2023, is actively seeking new participants. Approximately 26 individuals must be recruited from a single site."

Answered by AI

Is enrollment for this medical experiment currently available?

"Confirmed, this clinical trial is actively recruiting participants. Initially posted on July 12th 2023 with a recent update occurring the following day; information can be found on clinicaltrials.gov."

Answered by AI

What eligibility requirements must be met to participate in this trial?

"This experiment is seeking 26 children aged 8-17 with Autism Spectrum Disorder (ASD). Necessary criteria for enrolment include: outpatient status between ages 8 and 17 during year one, DSM-5 diagnosis of ASD confirmed by the ADI-R and the ADOS-2 tests, gender non specific, PSG data available as well as actigraphy results from a CSHQ score higher than 41 with a sleep efficiency lower than 80%, reliable care providers to interact regularly with participants and accompany them to appointments while maintaining stable medication regimens for 4 weeks or more, willingness to provide saliva samples and take part in key procedures such as"

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trial of Zolpidem for Sleep in Children With Autism
Antonio Hardan 2023. "Trial of Zolpidem for Sleep in Children With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540574.
All > Sleep
~17 spots leftby Apr 2027
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