Treatment of Sleep Disturbance in Children With ASD

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Education University of Hong Kong
• Collaborators: Castle Peak Hospital; Chinese University of Hong Kong; United Christian Hospital; University of Leicester
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• age 8 - 12 years

• clinical diagnosis of ASD from a physician or clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) and confirmed with the Autism Diagnostic Interview- Revised (ADI-R)

• pre-puberty as indicated by Tanner stage I through screening by a physician

• being given an average of 8 hours of sleep per night by their parents over the past 3 months

• parents reported sleep onset delays of 30 minutes of longer on three or more nights per week

• free of psychotropic medications (allergy medications and medications for constipation are allowed)

• non-verbal IQ over 40

• able to perform the requested physical intervention.

Exclusion Criteria:

• with one or co-morbid psychiatric disorders identified with a structured interview based on DSM-5

• with other medical conditions that limit their physical activity participation and sleep (e.g., asthma, seizure, cardiac disease etc)

• with a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)

• participants who are currently meeting physical activity guidelines (more than or equal to 60 minutes of moderate and vigorous physical activity each day).