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NCT07381504Recruiting

Aerobic Exercise for Sleep in Children With ASD

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

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impairments in social interaction and communication. Children with ASD frequently experience co-occurring behavioral problems, among which sleep disturbances are highly prevalent, affecting approximately 40%-80% of children and adolescents with ASD. These sleep problems pose a substantial burden during childhood and adolescence. This study employs a two-phase design to examine the effects of an acute aerobic exercise intervention combined with a parent-mediated cognitive behavioral program on sleep problems in children with autism spectrum disorder (ASD). Phase 1 consists of cross-sectional assessments comparing sleep efficiency, physical fitness, and attentional performance among children with ASD with and without sleep problems and typically developing children. Phase 2 is a randomized controlled intervention trial involving children with ASD and comorbid sleep problems, in which participants are assigned to either an aerobic exercise plus cognitive behavioral intervention group or a control group receiving cognitive behavioral strategy materials only. The intervention lasts two weeks. Outcomes related to autistic symptoms, sleep efficiency, physical activity level, attentional performance , and adaptive behaviors are assessed before and after the intervention to evaluate intervention effects.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
28 Dec 2025
Start date
15 Apr 2025
Primary completion date
31 Jul 2026
Lead sponsor
National Taiwan University Hospital
Diseases
Autism
NCT number
NCT07381504

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 15 Apr 2025 to the primary completion date, 31 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Children who are unable to participate in vigorous physical activity due to any medical condition
  • Children with other psychiatric disorders.

Other

  • Children with physical disabilities or visual or hearing impairments

Who the study is looking for

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

Age in the registry: 3 years to 11 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
School and Graduate of Physical Therapy
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.