Physical ActivityNCT03348982
Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder
A study testing Jogging program in people with Physical Activity and Sleep Apnea, run by The Hong Kong Polytechnic University.
Trial summary
This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD, and investigate how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Physical Activity, Sleep Apnea, Autism Spectrum Disorder
- What is being tested?
- Jogging program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jun 2019
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pre-puberty or early puberty as indicated by Tanner stage I or II ;
- ASD diagnosis from a physician based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V)[42]
- non-verbal IQ over 40
- the ability to follow instructions;
- physically able to participate in the intervention
- no additional regular participation in physical exercise other than school physical education classes for at least 6 months prior to the study
- no concurrent medication for at least 6 months before the study or any prior melatonin treatment;
- have sleep difficulties, including sleep onset insomnia and frequent and prolonged nightwaking and/or early morning awakenings reported by parents
Who cannot join
- with one or co-morbid psychiatric disorders as established by a structured interview based on DSM-V
- with other medical conditions that limit their physical activity capacities (e.g., asthma, seizure, cardiac disease);
- with a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder Using Melatonin-mediated Mechanism Model: A Randomized Controlled Trial
This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD, and investigate how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model. A parallel-group randomized controlled trial comparing a 12-week jogging intervention and a control group receiving standard care in 32 children with ASD will be conducted. This study will monitor the changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep onset and sleep duration) through objective actigraphic assessment and parental sleep logs.
Read the detailed description
Sleep disturbance is commonly found in children with autism spectrum disorder (ASD) and is often accompanied with family distress. Disturbed sleep may exacerbate the core symptoms of ASD including stereotypic behaviors, social interactions, and health problems. Therefore, it is important to develop effective intervention strategies to ameliorate the sleep disturbance in children with ASD. Traditionally, behavioral interventions and supplemental melatonin medication are used to improve their sleep quality. However, poor sustainability of behavioral intervention effects and use of other medications (e.g. antidepressants and stimulants) that metabolize melatonin may degrade the effectiveness of these interventions. Alternatively, previous research supported physical activity intervention as an effective treatment on sleep disturbance for typically developing children who suffered from sleep disturbance. It is therefore natural to extend the study to examine whether such intervention is also effective in children with ASD. This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD. Moreover, how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model will also be investigated. According to this mechanism model, it is suggested that physical activity could affect circadian rhythm through altering melatonin level. Melatonin is generally lower in ASD children than in their typically developing counterparts and supplemental melatonin medication is often used to treat the sleep disturbance in this population. This study is a parallel-group randomized controlled trial comparing a 12-week jogging intervention and a control group receiving standard care in 32 children with ASD. The changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep onset and sleep duration) through objective actigraphic assessment and parental sleep logs will be monitored. To measure melatonin level, all participants will be instructed to collect a 24-h urinary sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative for melatonin level, will be measured from the collected urine sample. All the assessments will be carried out before the intervention (T1), immediately after the 12 weeks of physical activity intervention or regular treatment (T2), and 12 weeks after post-intervention (T3) for examination of sustained intervention effect. The findings of this proposed study can provide information on the mechanism pathway that physical activity impacts on sleep in children with ASD, which will contribute to the design of an effective intervention to improve sleep quality for children with ASD.
- Conditions
- Physical Activity, Sleep Apnea, Autism Spectrum Disorder
- Being tested
- Jogging program
- Keywords
- Physical activity, Sleep, Children, Autism Spectrum Disorder, Melatonin
- Medical subject headings
- Motor Activity, Sleep Apnea Syndromes, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jogging programBehavioural
The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session) in a hall/gymnasium of each participating school.Each intervention session will be conducted in the morning by a trained research assistant assisted by student helpers. Each intervention session will be conducted in an identical format, comprising three activities: warm-up (5 min), jogging (20 min), and cool-down (5 min). In the jogging activity, participants will be asked to jog side-by-side with the research staff around an activity circuit (57m x 50m) marked with 4 red cones. Receives: Behavioral: Jogging program |
| Control group | No intervention | Participants in the control group will receive no physical intervention and will be required to follow their daily routine without participating in any additional physical activity/exercise program throughout the whole study period (T1-T3). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset latency
Sleep onset latency (length of time taken to fall asleep, expressed in minutes, SOL) will be objectively measured by a GT3X accelerometer.
Measured: 12-week
Sleep efficiency
Sleep efficiency (actual sleep time divided by time in bed, expressed as a percent, SE) will be objectively measured by a GT3X accelerometer.
Measured: 12-week
Wake after sleep onset
Wake after sleep onset (length of time they were awake after sleep onset, expressed in minutes, WASO) will be objectively measured by a GT3X accelerometer.
Measured: 12-week
Sleep duration
sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.
Measured: 12-week
Parental-assessed sleep quality
Participants' sleep patterns will be logged by their parents using Children's Sleep Habits Questionnaire (CSHQ), which is a validated 45-item parent-administered questionnaire to examine sleep patterns of young children. The total score ranged from 45 to 135.
Measured: 12-week
Melatonin
All participants will be instructed to collect a 24-h urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative of melatonin level, will be measured from the sample. The weekend has been chosen to allow the participants to stay at home for sample collection. All urine samples will be collected using 24-h urine bottles containing 0.1L of 0.5M hydrochloric acid as a preservative.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348982
- Sponsor's protocol ID
- 28602517
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tse ACY, Lee PH, Zhang J, Lai EWH. Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model. BMJ Open. 2018 Apr 13;8(4):e020944. doi: 10.1136/bmjopen-2017-020944.
PubMed 29654045
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder Using Melatonin-mediated Mechanism Model: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03348982
- Acronym / sponsor ID
- 28602517
- Conditions
- Physical Activity, Sleep Apnea, Autism Spectrum Disorder
- Keywords
- Physical activity, Sleep, Children, Autism Spectrum Disorder, Melatonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 21 Nov 2017 (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.
This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD, and investigate how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model. A parallel-group randomized controlled trial comparing a 12-week jogging intervention and a control group receiving standard care in 32 children with ASD will be conducted. This study will monitor the changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep onset and sleep duration) through objective actigraphic assessment and parental sleep logs.
Detailed description
Sleep disturbance is commonly found in children with autism spectrum disorder (ASD) and is often accompanied with family distress. Disturbed sleep may exacerbate the core symptoms of ASD including stereotypic behaviors, social interactions, and health problems. Therefore, it is important to develop effective intervention strategies to ameliorate the sleep disturbance in children with ASD. Traditionally, behavioral interventions and supplemental melatonin medication are used to improve their sleep quality. However, poor sustainability of behavioral intervention effects and use of other medications (e.g. antidepressants and stimulants) that metabolize melatonin may degrade the effectiveness of these interventions. Alternatively, previous research supported physical activity intervention as an effective treatment on sleep disturbance for typically developing children who suffered from sleep disturbance. It is therefore natural to extend the study to examine whether such intervention is also effective in children with ASD. This study aims to investigate whether physical activity intervention would be effective to improve sleep quality in children with ASD. Moreover, how physical activity impacts on sleep in children with ASD through melatonin-mediated mechanism model will also be investigated. According to this mechanism model, it is suggested that physical activity could affect circadian rhythm through altering melatonin level. Melatonin is generally lower in ASD children than in their typically developing counterparts and supplemental melatonin medication is often used to treat the sleep disturbance in this population. This study is a parallel-group randomized controlled trial comparing a 12-week jogging intervention and a control group receiving standard care in 32 children with ASD. The changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep onset and sleep duration) through objective actigraphic assessment and parental sleep logs will be monitored. To measure melatonin level, all participants will be instructed to collect a 24-h urinary sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative for melatonin level, will be measured from the collected urine sample. All the assessments will be carried out before the intervention (T1), immediately after the 12 weeks of physical activity intervention or regular treatment (T2), and 12 weeks after post-intervention (T3) for examination of sustained intervention effect. The findings of this proposed study can provide information on the mechanism pathway that physical activity impacts on sleep in children with ASD, which will contribute to the design of an effective intervention to improve sleep quality for children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Jogging programThe intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session) in a hall/gymnasium of each participating school.Each intervention session will be conducted in the morning by a trained research assistant assisted by student helpers. Each intervention session will be conducted in an identical format, comprising three activities: warm-up (5 min), jogging (20 min), and cool-down (5 min). In the jogging activity, participants will be asked to jog side-by-side with the research staff around an activity circuit (57m x 50m) marked with 4 red cones. |
| Control group | No intervention | –Participants in the control group will receive no physical intervention and will be required to follow their daily routine without participating in any additional physical activity/exercise program throughout the whole study period (T1-T3). |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- pre-puberty or early puberty as indicated by Tanner stage I or II ;
- ASD diagnosis from a physician based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V)[42]
- non-verbal IQ over 40
- the ability to follow instructions;
- physically able to participate in the intervention
Key exclusion criteria (3 listed)
- with one or co-morbid psychiatric disorders as established by a structured interview based on DSM-V
- with other medical conditions that limit their physical activity capacities (e.g., asthma, seizure, cardiac disease);
- with a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
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 |
|---|---|---|
| Jogging programThe intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session). | Behavioural | Intervention group |
Primary outcome
Sleep onset latency
Time frame: 12-week
Sleep onset latency (length of time taken to fall asleep, expressed in minutes, SOL) will be objectively measured by a GT3X accelerometer.
Sleep efficiency
Time frame: 12-week
Sleep efficiency (actual sleep time divided by time in bed, expressed as a percent, SE) will be objectively measured by a GT3X accelerometer.
Wake after sleep onset
Time frame: 12-week
Wake after sleep onset (length of time they were awake after sleep onset, expressed in minutes, WASO) will be objectively measured by a GT3X accelerometer.
Sleep duration
Time frame: 12-week
sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.
Parental-assessed sleep quality
Time frame: 12-week
Participants' sleep patterns will be logged by their parents using Children's Sleep Habits Questionnaire (CSHQ), which is a validated 45-item parent-administered questionnaire to examine sleep patterns of young children. The total score ranged from 45 to 135.
Melatonin
Time frame: 12-week
All participants will be instructed to collect a 24-h urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative of melatonin level, will be measured from the sample. The weekend has been chosen to allow the participants to stay at home for sample collection. All urine samples will be collected using 24-h urine bottles containing 0.1L of 0.5M hydrochloric acid as a preservative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Derived from this study: PubMed 29654045Tse ACY, Lee PH, Zhang J, Lai EWH. Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model. BMJ Open. 2018 Apr 13;8(4):e020944. doi: 10.1136/bmjopen-2017-020944.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Jogging program in people with Physical Activity and Sleep Apnea, run by The Hong Kong Polytechnic University.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy CY Tse, PhD (29488074, andytcy@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset latency (time frame: 12-week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348982, which also lists 1 linked publication.
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 6 Dec 2017.