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New sleep program aims to help kids with autism sleep better

NCT ID NCT07007819

Symptom relief Sponsor: Case Western Reserve University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study tests a behavioral sleep and circadian intervention for 50 school-aged children (6–12 years) with autism who have sleep problems. Parents receive 5 Zoom sessions over 12 weeks to learn strategies to improve their child's sleep. The goal is to see if the program is feasible and improves sleep, daytime behavior, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral sleep and circadian intervention
What this could lead to
If successful, this could provide a practical, non-drug approach to improve sleep and daytime behavior in children with autism.
What could go wrong
This is a small, early pilot study with only 50 participants, so results may not apply to all children. The intervention requires active parent involvement, which may not work for every family.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children 6-12 years with a clinical diagnosis of ASD defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition and corroborated by the Social Communication Questionnaire-lifetime score of ≥ 15. 2. Child must have ≥ 1 poor sleep health dimensions (B-SATED). 3. Child is not currently participating in any sleep-related interventions. 4. Child has not had any medication changes within the past month that interfere with sleep. 5. If present, the child must have a treated OSA (mild or less) diagnosis and willingness to continue treatment (≥80% adherence). 6. Parent must be an adult legal guardian proficient in English. Exclusion Criteria: 1. Children with an untreated complex medical condition that interferes with sleep (e.g., epilepsy, nocturnal seizures). 2. Children with moderate to severe OSA. 3. Unable to complete protocol (e.g., serious behavioral concerns, bereavement, currently homeless).

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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