Effect of Nap on Daytime Functioning in Primary School Students

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT04270539
• Collaborator: Chinese University of Hong Kong (Other)
• Enrollment: 654
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 27.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation	Behavioral: Nap	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 654 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Experimental group (with daytime classroom nap) versus control group (without nap)Experimental group (with daytime classroom nap) versus control group (without nap)
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessors who are responsible for conducting the cognitive tests are blinded to the group allocation.
• Primary Purpose: Treatment
• Official Title: Effects of Short Daytime Nap on Neurocognitive Functioning and Behavior in Chinese Primary School Children
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

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.	Behavioral: Nap; Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.
No Intervention: Control Group (no nap) The control group will not be allowed to take daily nap on school days during the study period.

Outcome Measures

Primary Outcome Measures

1. Change in objectively measured cognitive performance (sustained attention) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   Reaction time (ms) in psychomotor vigilance task

2. Change in objectively measured cognitive performance (sustained attention) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   Lapses defined by reaction time (RT) more than 500ms in psychomotor vigilance task

3. Change in objectively measured cognitive performance (inhibitory control) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   false alarm rate (%) in Go-no go task

4. Change in objectively measured cognitive performance (inhibitory control) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   reaction time (ms) in Go-no go task

5. Change in objectively measured cognitive performance (working memory) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   reaction time (ms) in match to sample task

6. Change in objectively measured cognitive performance (working memory) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   accuracy in match to sample task

Secondary Outcome Measures

1. Change in daytime sleepiness [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   Daytime sleepiness as measured by Pediatric Daytime Sleepiness Scale (PDSS). Higher scores suggest more sleepiness.

2. Change in daytime behaviour (emotional & behavioural problems) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   Daytime behaviors as measured by Strengths and Difficulties Questionnaires (SDQ). Higher scores suggest more emotional and behavioural problems.

3. Change in daytime behaviour (ADHD symptoms) [Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention]

   Strengths and Weakness of Attention-Deficit/ Hyperactivity-symptoms and Normal-behaviors (SWAN). Higher scores suggest more severe ADHD symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Children from grade 1, 2, 3, 5, and 6

Exclusion Criteria:

• Children ages 4 or younger, ages 15 or older

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

• The University of Hong Kong
• Chinese University of Hong Kong

Investigators

• Principal Investigator: Shirley X. Li, PhD, DClinPsy, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Shirley Xin Li, Assistant Professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04270539
• Other Study ID Numbers: EA1807008
• First Posted: Feb 17, 2020
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Shirley Xin Li, Assistant Professor, The University of Hong Kong: primary school children; nap; sleep deprivation
• Additional relevant MeSH terms: Sleep Deprivation

Study Results

No Results Posted as of Apr 27, 2021