NCT02838095

Brief Summary

To examine the neurobehavioural responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15 days. The nap group received an afternoon sleep opportunity lasting 1 hour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

June 15, 2016

Last Update Submit

July 15, 2016

Conditions

Keywords

napsleep restrictionrecovery sleepcognitive performancesubjective sleepinessmoodneurobehavioural functions

Outcome Measures

Primary Outcomes (8)

  • Change in sustained attention assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Number of attention lapses (\>500ms)

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in working memory assessed with the 1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Number of correct responses in the 1-back task

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in executive functions assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Number of correct responses in the 3-back task

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in the level of subjective sleepiness assessed with the Karolinska Sleepiness Scale from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Score on the Karolinska Sleepiness Scale (1-9 points)

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in positive mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Total score on the positive subscale of the PANAS

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in negative mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Total score on the negative subscale of the PANAS

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in speed of processing assessed with the Mental Arithmetic Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Number of correct responses in the task

    3 times daily (10:00, 15:45, and 20:00) for 15 days

  • Change in speed of processing assessed with the Symbol Digit Modalities Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery

    Number of correct responses in the task

    3 times daily (10:00, 15:45, and 20:00) for 15 days

Secondary Outcomes (10)

  • Change in total sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery

    Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)

  • Change in N1 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery

    Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)

  • Change in N2 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery

    Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)

  • Change in N3 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery

    Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)

  • Change in REM sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery

    Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)

  • +5 more secondary outcomes

Study Arms (2)

No nap

NO INTERVENTION

After each night with a 5-hour sleep opportunity, participants did not have a daytime nap opportunity, but instead watched documentaries.

Nap

EXPERIMENTAL

After each night with a 5-hour sleep opportunity, participants had the chance to take a daytime nap from 14:00 to 15:00.

Behavioral: Nap

Interventions

NapBEHAVIORAL

A 1-hour daytime nap opportunity

Nap

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy
  • no sleep disorder
  • body mass index not greater than 30

You may not qualify if:

  • smoker
  • habitual short sleeper (time in bed during term time of less than 6 hours and no sign of sleep extension of greater than 1 hour on weekends)
  • consumption of more than 5 cups of caffeinated beverages a day
  • travelling across more than 2 time zones in the month prior to the study protocol
  • diagnosed with any psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS Medical School

Singapore, Singapore, 169857, Singapore

Location

Related Publications (2)

  • Lo JC, Ang JWA, Koa TB, Ong JL, Lim J. Predicting vigilance vulnerability during 1 and 2 weeks of sleep restriction with baseline performance metrics. Sleep Adv. 2022 Oct 25;3(1):zpac040. doi: 10.1093/sleepadvances/zpac040. eCollection 2022.

  • Lo JC, Koa TB, Ong JL, Gooley JJ, Chee MWL. Staying vigilant during recurrent sleep restriction: dose-response effects of time-in-bed and benefits of daytime napping. Sleep. 2022 Apr 11;45(4):zsac023. doi: 10.1093/sleep/zsac023.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael WL Chee, MBBS

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Neuroscience and Behavioural Disorders Program; Director, Centre for Cognitive Neuroscience

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 20, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations