Clinical trial Recruiting at 1 site Interventional Ages 3 to 11

Aerobic exercise to improve sleep in children with autism

Official title: Acute Aerobic Exercise Intervention for Children With Autism Spectrum Disorder and Co-Occurring Sleep Disorder

Run by National Taiwan University Hospital · NCT07381504 · Data updated 2026-11-12

This trial will try whether short bouts of moderate-to-vigorous aerobic exercise combined with parent-led cognitive behavioral training can improve sleep in children aged 3–11 with autism who have sleep problems.

Quick facts

Study typeInterventional
Ages3 Years to 11 Years
SexAll
Enrollment120 (estimated)
SponsorNational Taiwan University Hospital
Academic / other
Locations1 site (Taipei)
StatusRecruiting
StartedApril 15, 2025
Main results expectedJuly 31, 2026
Study endsAugust 1, 2026
Registry record updatedJuly 14, 2026
Trial IDNCT07381504 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 3–11 with a clinical diagnosis of autism spectrum disorder who have comorbid sleep problems, can safely perform moderate-to-vigorous exercise, and do not have genetic/chromosomal disorders or other psychiatric or sensory/physical impairments.

Probably not a fit

Children who cannot safely engage in vigorous physical activity, who have genetic or chromosomal disorders, significant sensory or physical impairments, or other psychiatric diagnoses are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a two-phase design: Phase 1 compares sleep efficiency, physical fitness, and attention across children with autism with and without sleep problems and typically developing peers. Phase 2 is a randomized two-week intervention for children with autism and comorbid sleep problems, comparing twice-weekly, 30-minute supervised intermittent moderate-to-vigorous aerobic exercise plus parent-mediated cognitive behavioral strategies versus the cognitive behavioral program alone. Exercise intensity is prescribed and monitored using heart rate criteria, and parents receive structured training in sleep-related behavioral strategies. Primary outcomes include changes in sleep measures, with secondary outcomes of fitness and attentional performance.

Why it matters

Potential benefit: If successful, this approach could offer a short, non-drug way to improve sleep and daytime functioning for children with autism.

How similar studies have gone: Prior research shows aerobic exercise and parent-led behavioral sleep interventions can improve sleep in children, but combining acute exercise with parent-mediated cognitive behavioral strategies in autism is relatively novel and not extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Children aged 3-11 years
2. Clinical diagnosis of Autism Spectrum Disorder and a comorbid sleep disorder
3. No diagnosis of genetic or chromosomal disorders, such as Down syndrome or Fragile X syndrome.

Exclusion Criteria:

1. Children with physical disabilities or visual or hearing impairments
2. Children who are unable to participate in vigorous physical activity due to any medical condition
3. Children with other psychiatric disorders.

Where it's running

  • School and Graduate of Physical Therapy
    Taipei, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.