NCT04878198Completed
Treatment of Sleep Disturbance in Children With ASD
Comparing the Effectiveness of Physical Exercise and Melatonin Supplement in Treating Sleep Disturbance in Children With ASD: A RCT Study
Source: ClinicalTrials.gov · Last updated 28 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 4 May 2021
- Start date
- 2 Dec 2022
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Education University of Hong Kong
- Diseases
- Autism
- NCT number
- NCT04878198
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 2 Dec 2022 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- participants who are currently meeting physical activity guidelines (more than or equal to 60 minutes of moderate and vigorous physical activity each day).
Who the study is looking for
- 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.
Age in the registry: 8 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| EdUHK Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.