Sleep Intervention for Autism Spectrum Disorder

Overseen By Megan L Wenzell, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Epilepsy, Nocturnal seizures, Moderate OSA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist children with autism spectrum disorder (ASD) who struggle with sleep. Researchers are testing a modified sleep and circadian intervention, designed to improve sleep patterns, to determine its effects on sleep habits, daytime behavior, and parental stress. Children aged 6-12 with ASD who experience issues like difficulty falling asleep or staying asleep may be suitable candidates. Participants will either receive the new intervention or continue with their usual care for 12 weeks. The trial will assess how well these approaches improve sleep and overall quality of life for both children and their parents. As an unphased trial, this study provides a unique opportunity for families to contribute to research that could enhance sleep and quality of life for children with ASD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, your child should not have had any medication changes in the past month that interfere with sleep.

What prior data suggests that this intervention is safe for children with autism spectrum disorder?

Research has shown that sleep problems are common in children with autism, affecting over 80% of them. These issues can include difficulty falling asleep, staying asleep, or waking up too early. Sleep problems often occur alongside challenges like behavioral issues and anxiety.

The sleep and circadian intervention under study aims to improve various aspects of sleep, such as sleep quality and duration. While specific safety data from previous studies on this exact intervention is unavailable, behavioral sleep interventions are generally considered safe. They typically involve techniques like setting regular sleep schedules and creating bedtime routines, which are non-invasive and have a low risk of side effects.

Even without direct safety data, it is reasonable to believe this type of intervention is well-tolerated. This is especially true because the trial is in an early stage, focusing on safety and feasibility. Behavioral interventions typically pose minimal risk, making them a promising option for helping children with autism improve their sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Modified Sleep and Circadian Intervention for children with Autism Spectrum Disorder because it targets sleep and circadian rhythms directly, unlike most current treatments that often focus on behavioral therapies or medications like melatonin. This approach is unique because it aims to adjust the body's natural sleep-wake cycle, potentially improving overall sleep quality and daily functioning. By aligning sleep patterns more closely with natural circadian rhythms, this intervention could offer a more holistic and less invasive alternative to existing treatments.

What evidence suggests that this modified sleep and circadian intervention is effective for improving sleep in children with autism?

Research has shown that sleep problems are common in children with autism, affecting over 80% of them. Studies have found that behavioral sleep interventions can help children fall asleep and stay asleep more easily, with clear improvements compared to no treatment. In this trial, participants may receive the modified sleep and circadian intervention, designed to tackle various sleep issues, such as bedtime habits, sleep timing, and sleep duration. Early results suggest that these interventions could not only improve sleep but also enhance daytime behavior and overall quality of life for children with autism. By addressing these sleep aspects, the intervention aims to reduce problems like disruptive behavior and stress for parents. ^{1 2 4 6 7}

Who Is on the Research Team?

Megan L Wenzell, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for school-aged children (6-12 years) with a clinical diagnosis of Autism Spectrum Disorder who are not currently in any sleep-related interventions, have at least one poor sleep health dimension, and no recent medication changes affecting sleep. Parents must be proficient in English and legal guardians.

Inclusion Criteria

Child is not currently participating in any sleep-related interventions

My child is between 6-12 years old and has been diagnosed with ASD.

Parent must be an adult legal guardian proficient in English

Exclusion Criteria

My child has a complex medical condition like epilepsy that affects their sleep and hasn't been treated yet.

I am currently facing challenges that may prevent me from following the study's requirements.

My child has moderate to severe obstructive sleep apnea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a modified behavioral sleep and circadian intervention for 12 weeks

12 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Modified Sleep and Circadian Intervention

Trial Overview The study tests a modified behavioral sleep intervention against enhanced usual care over 12 weeks to improve multiple dimensions of sleep and assess its impact on daytime behavior, quality of life, parental stress, and self-efficacy in children with ASD.

How Is the Trial Designed?

Group I: Modified Sleep and Circadian Intervention Experimental Treatment 1 Intervention

Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks.

Group II: Enhanced Usual Care Control Condition Active Control 1 Intervention

Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725005453

Digital and telehealth behavioral sleep interventions for ... Analysis of sleep efficiency showed a statistically significant improvement in the intervention group compared to controls (MD = 3.68%, 95% CI [ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11046719/

Sleep and Autism: Current Research, Clinical Assessment ... Autism spectrum disorder is associated with a high rate of sleep problems, affecting over 80% of autistic individuals.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00691080

Understanding Sleep Problems in Children With Autism ... Data from this study will provide important information concerning circadian rhythm dysregulation in ASD and will support the development of future studies ...

4. withpower.com withpower.com/trial/phase-behavioral-sleep-and-circadian-intervention-6-2025-a2504

Sleep Intervention for Autism Spectrum Disorder The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) ...

5. mdpi.com mdpi.com/2076-3425/15/9/983

Sleep Disorders in Children with Autism Spectrum Disorder Sleep disorders are highly prevalent in children with Autism Spectrum Disorder (ASD), profoundly impacting their neurodevelopment and daily functioning.

6. sciencedirect.com sciencedirect.com/science/article/pii/S3050656525001579

The collateral effect of a brief behavioural sleep ... Autistic children have approximately twice the risk of developing sleep problems and greater likelihood of a later circadian rhythm preference (chronotype) ...

7. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A446/8136003

1031 Adapting a Community-Engaged Sleep Intervention for ... In ASD, shorter sleep duration < 7 hours and lower sleep efficiency < 85% are associated with disruptive behavior, anxiety and increased ...