Sleep DeprivationNCT04270539
Effect of Nap on Daytime Functioning in Primary School Students
A study testing Nap in people with Sleep Deprivation, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from grade 1, 2, 3, 5, and 6
Who cannot join
- Children ages 4 or younger, ages 15 or older
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- Nap
- Keywords
- primary school children, nap, sleep deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapBehavioural
Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (nap) | Experimental | The experimental group will be allowed to take a brief nap daily on school days during the study period. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objectively measured cognitive performance (sustained attention)
Reaction time (ms) in psychomotor vigilance task
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Secondary outcomes (3)
Change in daytime sleepiness
Daytime sleepiness as measured by Pediatric Daytime Sleepiness Scale (PDSS). Higher scores suggest more sleepiness.
Measured: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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.
Measured: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
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
Measured: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Dec 2018
- Primary completion1 May 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group (with daytime classroom nap) versus control group (without nap)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
- Investigators
- Shirley X. Li, PhD, DClinPsy, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270539
- Sponsor's protocol ID
- EA1807008
- Status last verified
- Apr 2021
- First submitted
- 3 Feb 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Daytime Nap on Neurocognitive Functioning and Behavior in Chinese Primary School Children
- ClinicalTrials.gov ID
- NCT04270539
- Acronym / sponsor ID
- EA1807008
- Conditions
- Sleep Deprivation
- Keywords
- primary school children, nap, sleep deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group (with daytime classroom nap) versus control group (without nap)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (nap) | Experimental | Behavioral: NapThe experimental group will be allowed to take a brief nap daily on school days during the study period. |
| Control Group (no nap) | No intervention | –The control group will not be allowed to take daily nap on school days during the study period. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from grade 1, 2, 3, 5, and 6
Key exclusion criteria (1 listed)
- Children ages 4 or younger, ages 15 or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NapParticipants will be given 20-min nap opportunity in the classroom on a daily basis during school-days. | Behavioural | Experimental Group (nap) |
Primary outcome
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
Reaction time (ms) in psychomotor vigilance task
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
Lapses defined by reaction time (RT) more than 500ms in psychomotor vigilance task
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
false alarm rate (%) in Go-no go task
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
reaction time (ms) in Go-no go task
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
reaction time (ms) in match to sample task
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
accuracy in match to sample task
3 secondary outcomes
Change in daytime sleepiness
Time frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Change in daytime behaviour (emotional & behavioural problems)
Time frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Change in daytime behaviour (ADHD symptoms)
Time frame: Day 1 (before napping), Day 1 (after napping), two weeks and two months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley X. Li, PhD, DClinPsy principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap in people with Sleep Deprivation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.