Treatment of Sleep Disturbance in Children With ASD

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.

Conditions

• Physical Exercise
• Sleep Disturbance
• Autism Spectrum Disorder
• Melatonin Deficiency

Interventions

BEHAVIORAL

Jogging program

This intervention consists of 50 sessions of morning jogging sessions at moderate intensity level. Each intervention session will be administered by a trained research assistant assisted by student helpers. All the research staff (i.e. student helpers and research assistant) will be required to attend a workshop (see educational plan) to standardize the procedure on implementing the intervention, as well as handling and motivating their ASD partners. Motivation techniques in previous protocol will be used to enhance the compliance rate.

DRUG

Melatonin supplement intervention

This intervention is a 10-week melatonin supplement intervention where melatonin supplement will be provided 30 minutes before bedtime.

Sponsors & Collaborators

• Chinese University of Hong Kong

  collaborator OTHER

• Castle Peak Hospital

  collaborator OTHER_GOV

• University of Leicester

  collaborator OTHER

• United Christian Hospital

  collaborator OTHER

• Education University of Hong Kong

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-02

Primary Completion

2023-06-30

Completion

2023-12-30

Countries

• Hong Kong

Study Locations