Sensory-Friendly Physical Activity for Sleep in Autistic Children

NCT07277101 | Completed DMC

• 2 other identifiers: SUS-APA-ASD-SLEEP-RCTSUS
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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, cluster-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.

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders

Keywords

autism; autistic children; sleep problems; insomnia; sensory-friendly physical activity; school-based intervention; exercise program; randomized trial; actigraphy

Outcome Measures

Primary Outcomes (4)

• Sleep Efficiency (SE)

  Actigraphy-derived sleep efficiency, calculated as (total sleep time / time in bed) × 100%, averaged across at least 3 consecutive nights at each assessment. Higher scores indicate more efficient sleep.

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Sleep Onset Latency (SOL)

  Actigraphy-derived sleep onset latency, defined as the number of minutes from lights out (bedtime) to the onset of sustained sleep, averaged across at least 3 consecutive nights at each assessment. Lower scores indicate faster sleep initiation.

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Total Sleep Time (TST)

  Actigraphy-derived total sleep time, defined as the total number of minutes scored as sleep between sleep onset and final morning waking, averaged across at least 3 consecutive nights at each assessment. Higher scores indicate longer nocturnal sleep duration.

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Wake After Sleep Onset (WASO)

  Actigraphy-derived wake after sleep onset, defined as the cumulative number of minutes scored as wake after initial sleep onset until final morning waking, averaged across at least 3 consecutive nights at each assessment. Lower scores indicate less fragmented sleep.

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

Secondary Outcomes (6)

• Daily Moderate-to-Vigorous Physical Activity (MVPA)

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Parental Sleep Quality (PSQI Total Score)

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Parenting Sense of Competence (PSOC Total Score)

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Caregiver Anxiety Symptoms (HADS-A Subscale Score)

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

• Caregiver Depressive Symptoms (HADS-D Subscale Score)

  Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

Study Arms (2)

PAP

EXPERIMENTAL

Classrooms receive a teacher-led, sensory-friendly physical activity program integrated into regular physical education lessons, 3 times per week for 16 weeks. Sessions include structured warm-up, adapted multi-component activities, and calming cool-down with breathing and relaxation in a low-arousal environment.

Behavioral: Sensory-Friendly Physical Activity Program (PAP)

CC

ACTIVE COMPARATOR

Classrooms continue usual school routines

Other: Conventional control group

Interventions

Sensory-Friendly Physical Activity Program (PAP) BEHAVIORAL

A structured, teacher-led physical activity program designed to be sensory-friendly for autistic children. Delivered in special education schools during scheduled physical education lessons, 3 sessions per week for 16 weeks. Each session includes predictable routines, warm-up, moderate-to-vigorous activities adapted for motor and sensory needs, and a cool-down with breathing and relaxation to support self-regulation and sleep readiness.

PAP

Conventional control group OTHER

Children follow the usual daily schedule

CC

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• (1) Current or prior pharmacological or behavioural treatment specifically targeting sleep.(2) Medical conditions that preclude participation in physical activity (e.g., asthma, congenital heart disease).(3) Comorbid complex neurological disorders (e.g., epilepsy) or other medical/psychiatric conditions likely to interfere with sleep.

Sponsors & Collaborators

• Xili Wen: lead

Study Sites (1)

Shanghai University of Sport, School of Physical Education and Training

Shanghai, 200438, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders; Autistic Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, School of Physical Education and Training, Shanghai University of Sport

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: June 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

CN (1)