Comparing the Effectiveness of Physical Exercise and Melatonin Supplement in Treating Sleep Disturbance in Children With ASD: A RCT Study
Abstract
This RCT study aims to compare effectiveness physical exercise and melatonin supplement on treating sleep disturbance in children with ASD. A four-arm randomized controlled trial with equal allocation ratio to the three intervention groups (i.e., jogging; melatonin supplement, combine jogging and melatonin supplement) and one placebo-control group will be conducted . Actigraph device and sleep log will be used for sleep assessment. 6-sulfoxymelatonin from 24-h and first morning urinary samples. The investigators will monitor the changes of four sleep parameters (sleep onset latency, sleep efficiency, wake after sleep onset and total sleep duration) and the 24-h and first morning melatonin level throughout the whole study.
Conditions: Physical Exercise, Sleep Disturbance, Autism Spectrum Disorder, Melatonin Deficiency.
Primary outcome: Sleep onset latency; Sleep efficiency; Wake after sleep onset; Sleep duration; Parental-assessed sleep quality; 24-h melatonin level; First morning void melatonin level.
Enrollment: 62 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 62 participants or records.
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