Aerobic exercise to improve sleep in children with autism
Acute Aerobic Exercise Intervention for Children With Autism Spectrum Disorder and Co-Occurring Sleep Disorder
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07381504 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Taipei
- School and Graduate of Physical Therapy — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yen-Tzu Wu, PhD
- Email: yenwu@ntu.edu.tw
- Phone: +8862963663269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.