Autism Spectrum DisorderSFPASNCT07277101
Sensory-Friendly Physical Activity for Sleep in Autistic Children
A study testing Sensory-Friendly Physical Activity Program (PAP) in people with Autism Spectrum Disorder and Sleep Initiation and Maintenance Disorders, run by Xili Wen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Sensory-Friendly Physical Activity Program (PAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Sport, School of Physical Education and Training
Shanghai, 200438
About this study
Official title: Sensory-friendly Physical Activity and Sleep in Autistic Children: A Randomized Controlled Trial
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.
Read the detailed description
This study is a multicenter, parallel-group, randomized controlled trial conducted in special education schools in China. Classrooms are the unit of randomization to minimize contamination between children in the same class. Eligible participants are children aged 7-12 years with a documented diagnosis of autism spectrum disorder who attend participating special schools, have at least one sleep difficulty (such as bedtime resistance, prolonged sleep onset, or night wakings), and live with a primary caregiver who can complete questionnaires in Mandarin and provide informed consent.
Classes are randomly assigned in a 1:1 ratio to either the sensory-friendly Physical Activity Program (PAP) or a control condition. The PAP is delivered by trained physical education teachers during scheduled lessons, three times per week for 16 weeks. Each session includes a structured warm-up, multi-component physical activities adapted for motor and sensory needs, and a cool-down segment with breathing and relaxation exercises in a low-arousal environment. Teachers receive manuals and on-site coaching to support fidelity. The control group follows usual school routines and physical education without the PAP.
The primary outcomes are actigraphy-derived sleep parameters: sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset. Secondary outcomes include accelerometer-measured daily physical activity; parent-reported sleep problems; and caregiver-reported sleep quality, anxiety and depressive symptoms, parenting sense of competence, and health-related quality of life. Data are collected at three time points: baseline (before randomization), immediately after the 16-week intervention, and 6-month follow-up. Linear mixed-effects models with random intercepts for classroom and child are used to estimate intervention effects while accounting for clustering and prespecified covariates.
- Being tested
- Sensory-Friendly Physical Activity Program (PAP), Conventional control group
- Keywords
- autism, autistic children, sleep problems, insomnia, sensory-friendly physical activity, school-based intervention, exercise program, randomized trial, actigraphy
- Medical subject headings
- Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders, Autistic Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory-Friendly Physical Activity Program (PAP)Behavioural
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.
Conventional control groupOther
Children follow the usual daily schedule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sensory-Friendly Physical Activity Program (PAP) |
| CC | Active comparator | Classrooms continue usual school routines Receives: Other: Conventional control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Secondary outcomes (6)
Daily Moderate-to-Vigorous Physical Activity (MVPA)
Accelerometer-measured daily minutes of moderate-to-vigorous physical activity (MVPA). Children wear a wrist-worn accelerometer for 7 consecutive days at each assessment. Days with at least 10 hours of valid wear time are retained, and the average daily MVPA minutes are calculated. Higher values indicate greater physical activity.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Parental Sleep Quality (PSQI Total Score)
Caregiver-reported global sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI yields a total score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Parenting Sense of Competence (PSOC Total Score)
The PSOC has 16 items rated on a 6-point Likert scale, yielding a total score from 16 to 96; higher scores indicate greater parenting sense of competence.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Anxiety Symptoms (HADS-A Subscale Score)
Caregiver anxiety symptoms measured by the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale comprises 7 items scored 0-3, yielding a total score from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Depressive Symptoms (HADS-D Subscale Score)
Caregiver depressive symptoms measured by the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale comprises 7 items scored 0-3, yielding a total score from 0 to 21, with higher scores indicating more severe depressive symptoms.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Health-Related Quality of Life (WHOQOL-BREF Domain Scores)
Health-related quality of life measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The instrument yields four domain scores (Physical Health, Psychological Health, Social Relationships, and Environment). Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jun 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xili Wen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xili Wen, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277101
- Sponsor's protocol ID
- SUS-APA-ASD-SLEEP-RCT
- Other IDs
- SUS
- Acronym
- SFPAS
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-friendly Physical Activity and Sleep in Autistic Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07277101
- Acronym / sponsor ID
- SFPAS / SUS-APA-ASD-SLEEP-RCT
- Keywords
- autism, autistic children, sleep problems, insomnia, sensory-friendly physical activity, school-based intervention, exercise program, randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Xili WenUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multicenter, parallel-group, randomized controlled trial conducted in special education schools in China. Classrooms are the unit of randomization to minimize contamination between children in the same class. Eligible participants are children aged 7-12 years with a documented diagnosis of autism spectrum disorder who attend participating special schools, have at least one sleep difficulty (such as bedtime resistance, prolonged sleep onset, or night wakings), and live with a primary caregiver who can complete questionnaires in Mandarin and provide informed consent.
Classes are randomly assigned in a 1:1 ratio to either the sensory-friendly Physical Activity Program (PAP) or a control condition. The PAP is delivered by trained physical education teachers during scheduled lessons, three times per week for 16 weeks. Each session includes a structured warm-up, multi-component physical activities adapted for motor and sensory needs, and a cool-down segment with breathing and relaxation exercises in a low-arousal environment. Teachers receive manuals and on-site coaching to support fidelity. The control group follows usual school routines and physical education without the PAP.
The primary outcomes are actigraphy-derived sleep parameters: sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset. Secondary outcomes include accelerometer-measured daily physical activity; parent-reported sleep problems; and caregiver-reported sleep quality, anxiety and depressive symptoms, parenting sense of competence, and health-related quality of life. Data are collected at three time points: baseline (before randomization), immediately after the 16-week intervention, and 6-month follow-up. Linear mixed-effects models with random intercepts for classroom and child are used to estimate intervention effects while accounting for clustering and prespecified covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAP | Experimental | Behavioral: Sensory-Friendly Physical Activity Program (PAP)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. |
| CC | Active comparator | Other: Conventional control groupClassrooms continue usual school routines |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory-Friendly Physical Activity Program (PAP)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. | Behavioural | PAP |
| Conventional control groupChildren follow the usual daily schedule | Other | CC |
Primary outcome
Sleep Efficiency (SE)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
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.
Sleep Onset Latency (SOL)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
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.
Total Sleep Time (TST)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
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.
Wake After Sleep Onset (WASO)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
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.
6 secondary outcomes
Daily Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Parental Sleep Quality (PSQI Total Score)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Parenting Sense of Competence (PSOC Total Score)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Anxiety Symptoms (HADS-A Subscale Score)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Depressive Symptoms (HADS-D Subscale Score)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Health-Related Quality of Life (WHOQOL-BREF Domain Scores)
Time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory-Friendly Physical Activity Program (PAP) in people with Autism Spectrum Disorder and Sleep Initiation and Maintenance Disorders, run by Xili Wen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (SE) (time frame: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.