Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04878198 |
Other study ID # |
RG 21/2019-2020R |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2, 2022 |
Est. completion date |
December 30, 2023 |
Study information
Verified date |
February 2024 |
Source |
Education University of Hong Kong |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Children with ASD are characterized by deficits to some extent - from mild to severe - in
social interaction, stereotyped behavior and limited interest. Apart from these core
symptoms, sleep disturbance is also commonly found in this population. To cope with sleep
problems, medication such as supplemental melatonin is commonly used. Melatonin is the
primary hormone produced by the pineal gland for properly timing circadian sleep/wake rhythms
to enhance sleepiness during night. Previous research indicated that children with ASD tend
to have abnormal melatonin secretion and this may contribute to the abnormal development of
sleep-wake cycles. Over the past decade, effect of supplemental melatonin on sleep
disturbance treatment has been studied widely in children with autism and the efficacy is
well recognized.
Apart from supplemental melatonin, researchers have also explored other intervention
strategies that could ameliorate the symptoms of sleep disturbance in children with ASD. One
intervention strategy that receives growing attention is physical exercise. Previous studies
showed that physical exercise could improve sleep quality in children with ASD. Then it is
natural to ask which intervention - physical exercise or melatonin supplement is more
effective to promote sleep health in the population. This proposed study aims to compare the
effectiveness of three interventions, namely, physical exercise, melatonin supplement and the
combination of the two, on treating sleep disturbance among children with ASD via a melatonin
mediated mechanism model. Two significant impacts will be expected. First, if the three
interventions were equally effective, then physical exercise, which is more naturalistic and
brings other health benefits, can be an alternative option for practitioners and parents to
treat sleep problems for their patients and children with ASD. Second, if there was a
difference between the three interventions on treating sleep problems, it will then inform
further research on the relationship between physical exercise, supplemental melatonin and
sleep. For example, if the combination was the most effective intervention to ameliorate the
sleep disturbance in children with ASD, it would imply the investigators may need to further
investigate other factors such as neurological factors (e.g. brain derived neurotrophic
factor) or psychological factors (e.g. happiness, motivation) that may play a role on
mediating the relationship between physical exercise and sleep. Each participant will attend
3 one-week-long assessments in their respective schools, where the investigators will assess
their habitual sleep patterns and endogenous melatonin level before the intervention (T1), in
the mid of the study (5 weeks after the commencement of the study) (T2) and after the 10-week
intervention (T3). The mid-assessment is valuable to know how much variance in sleep
behaviors is accounted by variance in melatonin, as well as to assess the adherence of the
interventions.
The findings of this study will allow the investigators to reaffirm if melatonin mediates the
relation between physical exercise and changes in sleep quality, which would further
strengthen the current limited evidence on the efficacy of physical exercise for sleep
problems in children with ASD. The findings of the proposed study will ultimately lead to
optimal treatment interventions for sleep disturbance not only in children with ASD, but also
in any population suffering from sleep disturbances.