Treatment of Sleep Disturbance in Children With ASD

NCT04878198 | Completed

• 1 other identifier: RG 21/2019-2020R
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autism; Children; Physical exercise; Melatonin; Sleep; Hong Kong; Jogging

Outcome Measures

Primary Outcomes (7)

• Sleep onset latency

  Sleep onset latency (length of time taken to fall asleep, expressed in minutes, SOL) will be objectively measured by a GT3X accelerometer

  10-week

• Sleep efficiency

  Sleep efficiency (actual sleep time divided by time in bed, expressed as a percent, SE) will be objectively measured by a GT3X accelerometer.

  10-week

• Wake after sleep onset

  Wake after sleep onset (length of time they were awake after sleep onset, expressed in minutes, WASO) will be objectively measured by a GT3X accelerometer.

  10-week

• Sleep duration

  Sleep duration (total sleep in hours and minutes, SD) will be objectively measured by a GT3X accelerometer.

  10-week

• Parental-assessed sleep quality

  Participants' sleep patterns will be logged by their parents using daily sleep diary.

  10-week

• 24-h melatonin level

  All participants will be instructed to collect a 24-h urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative of melatonin level, will be measured from the sample. The weekend has been chosen to allow the participants to stay at home for sample collection. All urine samples will be collected using 24-h urine bottles containing 0.1L of 0.5M hydrochloric acid as a preservative

  10-week

• First morning void melatonin level

  All participants will be instructed to collect the first morning void urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin and representative of melatonin level, will be measured from the sample. All urine samples will be collected using small urine bottles containing 0.1L of 0.5M hydrochloric acid as a preservative

  10-week

Study Arms (4)

Jogging intervention

EXPERIMENTAL

This intervention will be a 10-week jogging program consisting of 50 sessions (5 sessions per week, 30 min per session) in each participating school. The jogging program is confined to morning sessions based on the favourable sleep outcomes from previous study. To counteract the possible influence of natural sunlight exposure, all jogging sessions will be confined to indoor setting. Each session will be conducted in an identical format with 5 minutes of warm-up activities, followed by 20 minutes of jogging (intervention), and 5 minutes of cool-down activities. Participants are instructed to jog at a moderate intensity level. The intensity level of jogging will be measured by heart rate monitor (Polar H1). Meanwhile, questionnaire will be given to the research staff assisting the jogging intervention to assess the adherence of the intervention at T2.

Behavioral: Jogging program

Melatonin supplement group

EXPERIMENTAL

Participants in this intervention group will undergo a 10-week melatonin supplement intervention period, where melatonin supplement (Natrol®, Chatsworth CA) will be provided 30 minutes before bedtime. The prescription time (i.e. 30 minutes before bedtime) and the dosage of 3mg will be used because these are optimal for most of the participants as suggested by Malow and colleagues. 1 mg and 9 mg are not suggested to ensure the effectiveness of the intervention while preventing the potential daytime sleepiness. Similar to the aforementioned intervention, adherence of the intervention will be assessed at T2.

Drug: Melatonin supplement intervention

Combination group

EXPERIMENTAL

Participants will receive the jogging program and supplemental melatonin dose with identical format as that in the intervention A and B (e.g., identical duration, identical manpower, identical warm-up and cool-down, identical dose, identical acclimation procedure before the intervention adherence of the intervention for this group will also be assessed at T2.

Behavioral: Jogging program; Drug: Melatonin supplement intervention

Control group

NO INTERVENTION

Participants in the placebo control group will receive no jogging and melatonin supplement dosing activity. However, they will be given a placebo flavored similar to the melatonin supplement (compounded by Pharmacare, Mt. Juliet, NT®). Meanwhile, they will also be required to wear an actigraph to control for their physical activity level at the assessment points (i.e. T1, T2, and T3). They will be expected for following their daily routine without participating in any additional formal physical exercise training program throughout the whole study period (T1-T3). After T3, they will be assisted with jogging program to recognize their contribution as controls.

Interventions

Jogging program BEHAVIORAL

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.

Combination group; Jogging intervention

Melatonin supplement intervention DRUG

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

Combination group; Melatonin supplement group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Education University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• Castle Peak Hospital: collaborator
• University of Leicester: collaborator
• United Christian Hospital: collaborator

Study Sites (1)

EdUHK

Hong Kong, China, 0000, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity; Parasomnias; Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: December 2, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

HK (1)