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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

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
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
Introduction Sleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels. Methods and analysis All eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant's melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018. Ethics and dissemination Ethical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer-reviewed journals. Trial registration number NCT03348982.
children with autism spectrum disorders, melatonin, physical activity, sleep
2044-6055
Tse, Andy C.Y.
e0d6b2be-a736-43ac-b03e-d2d58a56e114
Lee, Paul H.
02620eab-ae7f-4a1c-bad1-8a50e7e48951
Zhang, Jihui
1f3ae372-3d78-4396-9d30-901b01496252
Lai, Elvis W.H.
055fbae1-3302-4285-960a-3a0e1f5cdee2
Tse, Andy C.Y.
e0d6b2be-a736-43ac-b03e-d2d58a56e114
Lee, Paul H.
02620eab-ae7f-4a1c-bad1-8a50e7e48951
Zhang, Jihui
1f3ae372-3d78-4396-9d30-901b01496252
Lai, Elvis W.H.
055fbae1-3302-4285-960a-3a0e1f5cdee2

Tse, Andy C.Y., Lee, Paul H., Zhang, Jihui and Lai, Elvis W.H. (2018) 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, 8 (4), [e020944]. (doi:10.1136/bmjopen-2017-020944).

Record type: Article

Abstract

Introduction Sleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels. Methods and analysis All eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant's melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018. Ethics and dissemination Ethical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer-reviewed journals. Trial registration number NCT03348982.

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More information

Accepted/In Press date: 15 March 2018
Published date: 13 April 2018
Additional Information: Funding Information: Funding This work was supported by the Early Career Scheme of Research Publisher Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Keywords: children with autism spectrum disorders, melatonin, physical activity, sleep

Identifiers

Local EPrints ID: 475073
URI: http://eprints.soton.ac.uk/id/eprint/475073
ISSN: 2044-6055
PURE UUID: b7ccd2cf-ed15-4336-9a96-8fc513b8cf63
ORCID for Paul H. Lee: ORCID iD orcid.org/0000-0002-5729-6450

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Date deposited: 09 Mar 2023 19:02
Last modified: 06 Jun 2024 02:15

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Contributors

Author: Andy C.Y. Tse
Author: Paul H. Lee ORCID iD
Author: Jihui Zhang
Author: Elvis W.H. Lai

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