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. 2022 Jul 6;17(7):e0270428.
doi: 10.1371/journal.pone.0270428. eCollection 2022.

Study protocol for a randomized controlled trial comparing the effectiveness of physical exercise and melatonin supplement on treating sleep disturbance in children with autism spectrum disorders

Andy Choi Yeung Tse  1 , Paul Hong Lee  2 , Esther Yuet Ying Lau  3 , James Ching Hei Cheng  4 , Amy Wing Yin Ho  5 , Elvis Wing Him Lai  6
Affiliations

Study protocol for a randomized controlled trial comparing the effectiveness of physical exercise and melatonin supplement on treating sleep disturbance in children with autism spectrum disorders

Andy Choi Yeung Tse et al. PLoS One. .

Abstract

Background: Previous study showed that both melatonin supplement and physical exercise intervention could improve sleep quality in children with autism spectrum disorders (ASD) with the increase in endogenous melatonin level. However, none of the studies have directly compared the effectiveness between the two interventions on treating sleep disturbance in children with ASD. Without direct comparison, we do not know which intervention is better. Thus, we designed a study to compare which intervention is more effective to treat sleep disturbance in children with ASD and to examine whether the combination of the two could be the most efficacious. We present a protocol for conducting a randomized controlled trial to compare the effectiveness of physical exercise and melatonin supplement on treating sleep disturbance in children with ASD.

Study design: The proposed study will be a four-group randomised control trial (RCT) design, with equal allocation of participants to the three intervention groups and one control group.

Methods: All eligible participants will be randomly allocated to a morning jogging group, a melatonin supplement group, a combination group and a control group. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. Melatonin levels represented by 6-sulfoxymelatonin will be measured from the participants' 24-h and the first morning void urinary samples. All the assessments will be carried out before the intervention (T1), in the mid of the study (5 weeks after the commencement of the study) (T2) and after the 10-week intervention (T3). Level of statistical significance will be set at 5% (i.e. p < .05). The results of this trial will be submitted for publication in peer-reviewed journal.

Findings: The findings will provide evidence to determine whether physical exercise or melatonin supplement or the combination of interventions is the most effective to treat sleep disturbance in children with ASD.

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Conflict of interest statement

The authors declare there is no competing interests with respect to the research, authorship, and/or publication of this article.

Figures

Fig 1
Fig 1. SPIRIT schedule of enrolment, interventions, and assessments of the study.
Fig 2
Fig 2. Flow diagram of the study.
See this image and copyright information in PMC

References

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