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NCT05540574 · ClinicalTrials.gov registry record · Phase 2

Trial of Zolpidem for Sleep in Children With Autism

A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Stanford University.

Recruiting
Registry status
Phase 2
Development phase
26
Enrollment target
1
Study location

NCT05540574 is a Phase 2 study of Autism Spectrum Disorder and Autism that is actively recruiting participants, run by Stanford University. The registered enrollment target is 26 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05540574, a Phase 2 study of Autism Spectrum Disorder and Autism, is actively recruiting participants, sponsored by Stanford University.

RECRUITING
Registry status
Phase 2
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Zolpidem

Study Locations (1)

California

  • Stanford University - Stanford

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2023-08-09
Est. Completion 2028-04-30
Phase Phase 2

Sponsor

Stanford University

1,744 total trials

What the Registry Record Tells You About NCT05540574

The ClinicalTrials.gov registry entry for NCT05540574 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05540574 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05540574 about?

NCT05540574 is a clinical study titled "Trial of Zolpidem for Sleep in Children With Autism". 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 place...

What is the current status of trial NCT05540574?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-08-09. Estimated completion is 2028-04-30.

What conditions does trial NCT05540574 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.

What interventions are being tested in trial NCT05540574?

The interventions under investigation include: Placebo (DRUG), Zolpidem (DRUG).

Who is sponsoring clinical trial NCT05540574?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05540574 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.