Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878198
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-05-04
Brief Title:
Treatment of Sleep Disturbance in Children With ASD
Sponsor:
Education University of Hong Kong
Organization:
Education University of Hong Kong
Study Overview
Official Title:
Comparing the Effectiveness of Physical Exercise and Melatonin Supplement in Treating Sleep Disturbance in Children With ASD A RCT Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
Detailed 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 sleepwake 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 eg brain derived neurotrophic factor or psychological factors eg 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
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 eg brain derived neurotrophic factor or psychological factors eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None