NCT04270539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
654

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

February 3, 2020

Last Update Submit

April 24, 2021

Conditions

Keywords

primary school childrennapsleep deprivation

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Change in daytime sleepiness

    Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention

  • Change in daytime behaviour (emotional & behavioural problems)

    Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention

  • Change in daytime behaviour (ADHD symptoms)

    Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention

Study Arms (2)

Experimental Group (nap)

EXPERIMENTAL

The experimental group will be allowed to take a brief nap daily on school days during the study period.

Behavioral: Nap

Control Group (no nap)

NO INTERVENTION

The control group will not be allowed to take daily nap on school days during the study period.

Interventions

NapBEHAVIORAL

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

Experimental Group (nap)

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children ages 4 or younger, ages 15 or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Shirley X. Li, PhD, DClinPsy

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors who are responsible for conducting the cognitive tests are blinded to the group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental group (with daytime classroom nap) versus control group (without nap)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 17, 2020

Study Start

December 1, 2018

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations