NCT07381504 Aerobic Exercise for Sleep in Children With ASD
| NCT ID | NCT07381504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-04-15 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381504 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 11 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07381504 currently recruiting?
Yes, NCT07381504 is actively recruiting participants. Contact the research team at yenwu@ntu.edu.tw for enrollment information.
Where is the NCT07381504 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07381504 clinical trial?
NCT07381504 is sponsored by National Taiwan University Hospital. The trial plans to enroll 120 participants.