- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270539
Effect of Nap on Daytime Functioning in Primary School Students
April 24, 2021 updated by: Dr. Shirley Xin Li, The University of Hong Kong
Effects of Short Daytime Nap on Neurocognitive Functioning and Behavior in Chinese Primary School Children
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
654
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children from grade 1, 2, 3, 5, and 6
Exclusion Criteria:
- Children ages 4 or younger, ages 15 or older
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group (nap)
The experimental group will be allowed to take a brief nap daily on school days during the study period.
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Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.
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No Intervention: Control Group (no nap)
The control group will not be allowed to take daily nap on school days during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in objectively measured cognitive performance (sustained attention)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Reaction time (ms) in psychomotor vigilance task
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in objectively measured cognitive performance (sustained attention)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Lapses defined by reaction time (RT) more than 500ms in psychomotor vigilance task
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in objectively measured cognitive performance (inhibitory control)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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false alarm rate (%) in Go-no go task
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in objectively measured cognitive performance (inhibitory control)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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reaction time (ms) in Go-no go task
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in objectively measured cognitive performance (working memory)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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reaction time (ms) in match to sample task
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in objectively measured cognitive performance (working memory)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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accuracy in match to sample task
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in daytime sleepiness
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Daytime sleepiness as measured by Pediatric Daytime Sleepiness Scale (PDSS).
Higher scores suggest more sleepiness.
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in daytime behaviour (emotional & behavioural problems)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Daytime behaviors as measured by Strengths and Difficulties Questionnaires (SDQ).
Higher scores suggest more emotional and behavioural problems.
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Change in daytime behaviour (ADHD symptoms)
Time Frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Strengths and Weakness of Attention-Deficit/ Hyperactivity-symptoms and Normal-behaviors (SWAN).
Higher scores suggest more severe ADHD symptoms
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Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shirley X. Li, PhD, DClinPsy, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 13, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 27, 2021
Last Update Submitted That Met QC Criteria
April 24, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA1807008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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