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Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder

Primary Purpose

Physical Activity, Sleep Apnea, Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Jogging program
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity focused on measuring Physical activity, Sleep, Children, Autism Spectrum Disorder, Melatonin

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    Sleep duration
    sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2017
    Last Updated
    December 5, 2017
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03348982
    Brief Title
    Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physical Activity, Sleep Apnea, Autism Spectrum Disorder
    Keywords
    Physical activity, Sleep, Children, Autism Spectrum Disorder, Melatonin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Jogging program
    Intervention Description
    The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).
    Primary Outcome Measure Information:
    Title
    Sleep onset latency
    Description
    Sleep onset latency (length of time taken to fall asleep, expressed in minutes, SOL) will be objectively measured by a GT3X accelerometer.
    Time Frame
    12-week
    Title
    Sleep efficiency
    Description
    Sleep efficiency (actual sleep time divided by time in bed, expressed as a percent, SE) will be objectively measured by a GT3X accelerometer.
    Time Frame
    12-week
    Title
    Wake after sleep onset
    Description
    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.
    Time Frame
    12-week
    Title
    Sleep duration
    Description
    sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.
    Time Frame
    12-week
    Title
    Parental-assessed sleep quality
    Description
    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.
    Time Frame
    12-week
    Title
    Melatonin
    Description
    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.
    Time Frame
    12-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andy CY Tse, PhD
    Phone
    29488074
    Email
    andytcy@eduhk.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul H Lee, PhD
    Phone
    34008275
    Email
    paul.h.lee@polyu.edu.hk

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29654045
    Citation
    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.
    Results Reference
    derived

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    Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum Disorder

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