Clinical Trial

Sensory-Friendly Physical Activity for Sleep in Autistic Children

Study acronym: SFPAS
Completed
View on ClinicalTrials.gov →
Summary
Sleep problems are very common in children on the autism spectrum and can worsen daytime behaviour, learning, and family stress. Many families have limited access to specialist sleep services. This study evaluates a school-based, sensory-friendly physical activity program designed to improve sleep and wellbeing in autistic children. This multicenter, parallel-group, randomized controlled trial was conducted in special education schools in China. Classrooms of children aged 7-12 years with a diagnosis of autism spectrum disorder were randomly assigned to either: (1) a teacher-led, sensory-friendly physical activity program integrated into regular physical education lessons for 16 weeks, or (2) usual school activities without the program. The intervention emphasized predictable routines, gradual warm-up, adjusted sensory input (for example, noise and light), and calming cool-down activities to support self-regulation and readiness for sleep. The primary outcomes are children's sleep parameters measured by wrist actigraphy, including sleep efficiency, sleep onset latency, sleep duration, and wake after sleep onset. Secondary outcomes include parent-reported sleep problems, children's daily moderate-to-vigorous physical activity, and caregivers' sleep quality, mental health, parenting sense of competence, and quality of life. Outcomes are assessed at baseline, immediately after the 16-week program, and 6 months after the program ends.
Trial Details
NCT Number NCT07277101
Lead Sponsor Xili Wen
Conditions Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders
Enrollment 106 participants
Start Date 2023-06-01
Primary Completion 2025-01-31 (estimated)
Study Completion 2025-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28