NCT04044885

Brief Summary

The aim of this study is to examine the neurobehavioural responses to two successive cycles of sleep manipulation nights and recovery nights in adolescents, and to determine the benefits of napping on cognitive performance, alertness and mood. Using a split-sleep design, 60 participants, aged 15 to 19 years old, are divided into a nap and a no-nap group. Both groups undergo two cycles of sleep manipulation nights and recovery nights over a period of 15 days. The no-nap group receives an 8-hour sleep opportunity on sleep restriction nights, with no daytime nap opportunity. The nap group receives a 6.5-hour sleep opportunity on sleep restriction nights, and has a 1.5-hour nap opportunity the following afternoon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

August 1, 2019

Last Update Submit

July 22, 2020

Conditions

Keywords

NapRecovery sleepCognitive functionsNeurobehavioural functionsMoodSubjective sleepiness

Outcome Measures

Primary Outcomes (14)

  • 1.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, 16:15, and 20:00) for 15 days

  • 2.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, 16:15, and 20:00) for 15 days

  • 3.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, 16:15, and 20:00) for 15 days

  • 4.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, 16:15, and 20:00) for 15 days

  • 5.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, 16:15, and 20:00) for 15 days

  • 6.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, 16:15, and 20:00) for 15 days

  • 7.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, 16:15, and 20:00) for 15 days

  • 8.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, 16:15, and 20:00) for 15 days

  • 11.Change in memory performance in picture-word association task over sleep restriction nights and recovery night

    Score on picture-word association task

    12 times (morning and evening): after sleep restriction night 1, 2, 3, 4 and 5 (sleep restriction period 1) and after recovery night 2 (recovery period 1)

  • 14.Effect of sleep versus wake during delay on memory for rewarded pictures, where the pictures will be encoded either before a 12-hr interval including a night of sleep or a day of wakefulness

    Memory score of correctly remembered encoded pictures following the wake or sleep

    Single session during the 15-day protocol, after baseline night 1 or before sleep restriction night 1 (first sleep restriction period)

  • 15.Effect of sleep restriction on learning of novel material (about different animal species) across separate sessions

    Memory score on test of learned material

    Single session during the 15-day protocol, after recovery night 2 (first recovery period)

  • 16.Effect of sleep restriction on memory of spatial locations

    Performance in four mountains task

    Single session during the 15-day protocol, after sleep restriction night 3 (first sleep restriction period)

  • 18.Effect of sleep restriction on picture encoding

    Memory score of correctly remembered encoded pictures of non-famous people, landscapes, scenes and objects

    Single session during the 15-day protocol, after recovery night 2 (second recovery period)

  • 19.Effect of sleep restriction on effort/temporal discounting

    Choice preference (perform a longer duration task for a higher reward, or to take a break for a lower/no reward) in effort/temporal discounting task is measured

    Three sessions during the 15-day protocol (after baseline night 1, after sleep restriction night 5 (first sleep restriction period) and after recovery night 2 (first recovery period))

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 & 2 (baseline), 3, 5 & 7 (first sleep restriction period), 8 (first recovery period), 10 & 12 (second sleep restriction period), & 13 (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 & 2 (baseline), 3, 5 & 7 (first sleep restriction period), 8 (first recovery period), 10 & 12 (second sleep restriction period), & 13 (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 & 2 (baseline), 3, 5 & 7 (first sleep restriction period), 8 (first recovery period), 10 & 12 (second sleep restriction period), & 13 (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 & 2 (baseline), 3, 5 & 7 (first sleep restriction period), 8 (first recovery period), 10 & 12 (second sleep restriction period), & 13 (second recovery period)

  • Change in Rapid Eye Movement (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 & 2 (baseline), 3, 5 & 7 (first sleep restriction period), 8 (first recovery period), 10 & 12 (second sleep restriction period), & 13 (second recovery period)

  • +5 more secondary outcomes

Study Arms (2)

Nap

EXPERIMENTAL

After each night with a 6.5-hour sleep opportunity, participants have a daytime nap opportunity of 1.5 hours.

Behavioral: Nap

No nap

NO INTERVENTION

After each night with a 8-hour sleep opportunity, participants do not have a daytime nap opportunity, but instead have free time.

Interventions

NapBEHAVIORAL

Looking at the difference between continuous sleep opportunities and split-sleep opportunities.

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, 169857, Singapore

Location

Related Publications (6)

  • Leong RLF, Tian L, Yu N, Teo TB, Ong JL, Chee MWL. Bidirectional associations between the duration and timing of nocturnal sleep and daytime naps in adolescents differ from weekdays to weekends. Sleep. 2024 Sep 9;47(9):zsae147. doi: 10.1093/sleep/zsae147.

  • Golkashani HA, Ghorbani S, Leong RLF, Ong JL, Chee MWL. Advantage conferred by overnight sleep on schema-related memory may last only a day. Sleep Adv. 2023 Apr 14;4(1):zpad019. doi: 10.1093/sleepadvances/zpad019. eCollection 2023.

  • Aghayan Golkashani H, Leong RLF, Ghorbani S, Ong JL, Fernandez G, Chee MWL. A sleep schedule incorporating naps benefits the transformation of hierarchical knowledge. Sleep. 2022 Apr 11;45(4):zsac025. doi: 10.1093/sleep/zsac025.

  • 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.

  • Leong RLF, Yu N, Ong JL, Ng ASC, Jamaluddin SA, Cousins JN, Chee NIYN, Chee MWL. Memory performance following napping in habitual and non-habitual nappers. Sleep. 2021 Jun 11;44(6):zsaa277. doi: 10.1093/sleep/zsaa277.

  • Lo JC, Leong RLF, Ng ASC, Jamaluddin SA, Ong JL, Ghorbani S, Lau T, Chee NIYN, Gooley JJ, Chee MWL. Cognitive effects of split and continuous sleep schedules in adolescents differ according to total sleep opportunity. Sleep. 2020 Dec 14;43(12):zsaa129. doi: 10.1093/sleep/zsaa129.

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
Principal Investigator, Professor

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

August 1, 2019

Primary Completion

December 10, 2019

Study Completion

December 31, 2019

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations