Back to resultsEffect of Nap on Daytime Functioning in Primary School Students
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Nap
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation focused on measuring primary school children, nap, sleep deprivation
Eligibility Criteria
Inclusion Criteria:
- Children from grade 1, 2, 3, 5, and 6
Exclusion Criteria:
- Children ages 4 or younger, ages 15 or older
Sites / Locations
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group (nap)
Control Group (no nap)
Arm Description
The experimental group will be allowed to take a brief nap daily on school days during the study period.
The control group will not be allowed to take daily nap on school days during the study period.
Outcomes
Primary Outcome Measures
Change in objectively measured cognitive performance (sustained attention)
Reaction time (ms) in psychomotor vigilance task
Change in objectively measured cognitive performance (sustained attention)
Lapses defined by reaction time (RT) more than 500ms in psychomotor vigilance task
Change in objectively measured cognitive performance (inhibitory control)
false alarm rate (%) in Go-no go task
Change in objectively measured cognitive performance (inhibitory control)
reaction time (ms) in Go-no go task
Change in objectively measured cognitive performance (working memory)
reaction time (ms) in match to sample task
Change in objectively measured cognitive performance (working memory)
accuracy in match to sample task
Secondary Outcome Measures
Change in daytime sleepiness
Daytime sleepiness as measured by Pediatric Daytime Sleepiness Scale (PDSS). Higher scores suggest more sleepiness.
Change in daytime behaviour (emotional & behavioural problems)
Daytime behaviors as measured by Strengths and Difficulties Questionnaires (SDQ). Higher scores suggest more emotional and behavioural problems.
Change in daytime behaviour (ADHD symptoms)
Strengths and Weakness of Attention-Deficit/ Hyperactivity-symptoms and Normal-behaviors (SWAN). Higher scores suggest more severe ADHD symptoms
Full Information
NCT ID
NCT04270539
First Posted
February 3, 2020
Last Updated
April 24, 2021
Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04270539
Brief Title
Effect of Nap on Daytime Functioning in Primary School Students
Official Title
Effects of Short Daytime Nap on Neurocognitive Functioning and Behavior in Chinese Primary School Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Previous studies showed that insufficient sleep has a negative impact on children's physical and psychological health. Napping was found to decrease sleepiness and improve daytime functioning in adults and adolescents. The effects of napping on children, however, is unknown. The current study aims to test the effects of short daytime classroom naps on daytime functioning and behaviour in elementary school children.
Detailed Description
This study is an interventional study testing the effects of short daytime nap on children's cognitive functioning and daytime behaviour. Primary school children will be randomised to either experimental (nap) or control group (no nap) by class. Measurements include parent-report questionnaires, children's self-report questionnaires, and cognitive tasks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
primary school children, nap, sleep deprivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group (with daytime classroom nap) versus control group (without nap)
Masking
Outcomes Assessor
Masking Description
Assessors who are responsible for conducting the cognitive tests are blinded to the group allocation.
Allocation
Randomized
Enrollment
654 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group (nap)
Arm Type
Experimental
Arm Description
The experimental group will be allowed to take a brief nap daily on school days during the study period.
Arm Title
Control Group (no nap)
Arm Type
No Intervention
Arm Description
The control group will not be allowed to take daily nap on school days during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Nap
Intervention Description
Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.
Primary Outcome Measure Information:
Title
Change in objectively measured cognitive performance (sustained attention)
Description
Reaction time (ms) in psychomotor vigilance task
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in objectively measured cognitive performance (sustained attention)
Description
Lapses defined by reaction time (RT) more than 500ms in psychomotor vigilance task
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in objectively measured cognitive performance (inhibitory control)
Description
false alarm rate (%) in Go-no go task
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in objectively measured cognitive performance (inhibitory control)
Description
reaction time (ms) in Go-no go task
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in objectively measured cognitive performance (working memory)
Description
reaction time (ms) in match to sample task
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in objectively measured cognitive performance (working memory)
Description
accuracy in match to sample task
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Secondary Outcome Measure Information:
Title
Change in daytime sleepiness
Description
Daytime sleepiness as measured by Pediatric Daytime Sleepiness Scale (PDSS). Higher scores suggest more sleepiness.
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in daytime behaviour (emotional & behavioural problems)
Description
Daytime behaviors as measured by Strengths and Difficulties Questionnaires (SDQ). Higher scores suggest more emotional and behavioural problems.
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Title
Change in daytime behaviour (ADHD symptoms)
Description
Strengths and Weakness of Attention-Deficit/ Hyperactivity-symptoms and Normal-behaviors (SWAN). Higher scores suggest more severe ADHD symptoms
Time Frame
Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children from grade 1, 2, 3, 5, and 6
Exclusion Criteria:
Children ages 4 or younger, ages 15 or older
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley X. Li, PhD, DClinPsy
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Nap on Daytime Functioning in Primary School Students
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