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Recruiting
NCT07381504
Aerobic Exercise for Sleep in Children With ASD
Conditions: Autism Spectrum Disorder
Sex: All
Ages: 3 Years – 11 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: National Taiwan University Hospital
Location: School and Graduate of Physical Therapy Taipei
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.
Source: ClinicalTrials.gov (NCT07381504). StuddyBuddy aggregates publicly available trial information.