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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04270539
Other study ID # EA1807008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date December 1, 2020

Study information

Verified date April 2021
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 654
Est. completion date December 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria: - Children from grade 1, 2, 3, 5, and 6 Exclusion Criteria: - Children ages 4 or younger, ages 15 or older

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nap
Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.

Locations

Country Name City State
Hong Kong Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
The University of Hong Kong Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in objectively measured cognitive performance (sustained attention) Reaction time (ms) in psychomotor vigilance task Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Primary Change in objectively measured cognitive performance (sustained attention) Lapses defined by reaction time (RT) more than 500ms in psychomotor vigilance task Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Primary Change in objectively measured cognitive performance (inhibitory control) false alarm rate (%) in Go-no go task Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Primary Change in objectively measured cognitive performance (inhibitory control) reaction time (ms) in Go-no go task Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Primary Change in objectively measured cognitive performance (working memory) reaction time (ms) in match to sample task Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Primary Change in objectively measured cognitive performance (working memory) accuracy in match to sample task Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Secondary Change in daytime sleepiness Daytime sleepiness as measured by Pediatric Daytime Sleepiness Scale (PDSS). Higher scores suggest more sleepiness. Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Secondary 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. Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Secondary 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 Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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