Clinical Trial

Aerobic Exercise for Sleep in Children With ASD

Recruiting
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Record status
This record was last updated July 14, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-15
Trial Details
NCT Number NCT07381504
Lead Sponsor National Taiwan University Hospital
Conditions Autism Spectrum Disorder
Enrollment 120 participants
Start Date 2025-04-15
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-14