An interventional study of Jogging program in Physical Activity, Sleep Apnea and Autism Spectrum Disorder, sponsored by The Hong Kong Polytechnic University. Status unknown. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
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.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 32 is below the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
Compared within Sleep Apnea Syndromes, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Jogging program
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).
The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).
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.
Time frame: 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.
Time frame: 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.
Time frame: 12-week
Sleep duration
sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.
Time frame: 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.
Time frame: 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.
Time frame: 12-week
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Jan 2018; primary completion for Jun 2019, 17 months later.
Of 200 non-industry interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 60. This study's planned 17 months is below that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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