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SleepNFS4NCT03333512

The Cognitive and Metabolic Effects of Sleep Restriction in Adolescents

A study testing Nap in people with Sleep and Sleep Restriction, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to examine the neurobehavioural and glucose metabolic responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, mood and glucose metabolism. Read more about this study

Who is it for?
Ages 15 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Sleep, Sleep Restriction
What is being tested?
Nap
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteSingapore
Study dates
28 Nov 2017to 20 Jan 2018
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 15 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Duke-NUS Medical School

    Singapore, 169857

Other trials in Singapore

About this study

The aim of this study is to examine the neurobehavioural and glucose metabolic responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, mood and glucose metabolism. 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 restriction and recovery over a period of 15 days. The no-nap group receives a 6.5-hour sleep opportunity on sleep restriction nights, with no daytime nap opportunity. The nap group receives a 5-hour sleep opportunity on sleep restriction nights, and has a 1.5-hour nap opportunity the following afternoon.

Read the detailed description

The present study investigates whether a continuous stretch of night time sleep (6.5 hours) will lead to better neurobehavioural outcomes relative to nocturnal sleep restriction (5 hours) and daytime nap (1.5 hours) of the same total duration, and how sleep restriction affects glucose metabolism. The 15-day protocol is conducted in a dormitory on 60 high school students, aged 15 to 19 years old. Participants are assigned to a nap or no-nap group. Both groups start with two 9-hour adaptation and baseline nights, followed by two successive cycles of sleep restriction (5-h time in bed (TIB); 01:00-06:00 or 6.5-h TIB; 00:15-06:45) and recovery (9-h TIB; 23:00-08:00). Following each sleep-restricted night, the nap group receives a 1.5-h nap opportunity, while participants in the no-nap group watch a documentary. Throughout the protocol, sleep-wake patterns are assessed with actigraphy and polysomnography. Sleepiness levels, mood, vigilance, working memory / executive functions, and speed of processing are assessed 3 times daily (10:00, 16:15, and 20:00). Other cognitive functions such as memory and mindfulness levels are investigated through computer-based tasks. Glucose metabolism is measured using oral glucose tolerance tests in the mornings after the second baseline night, the third night of sleep restriction and second recovery night in the first cycle, as well as the last sleep restriction night in the second cycle.

All participants stay in air-conditioned, twin-share bedrooms with en-suite bathrooms. Bedroom windows are fitted with blackout panels to ensure participants are not woken up prematurely by sunlight. Earplugs are provided, and participants are allowed to adjust the temperature of their bedrooms to their personal comfort. Three main meals are served each day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and strenuous physical activities are prohibited.

Outside of scheduled sleep, meal, and cognitive testing times, participants spend the majority of their free time in a common room that is illuminated by natural and artificial lighting. They are allowed to read, play non-physically exerting games, watch videos, and interact with research staff and other participants. Participants are under constant supervision by the research staff.

Being tested
Nap
Keywords
Nap, Recovery Sleep, Cognitive Functions, Glucose Metabolism, Neurobehavioral Functions, Mood, Subjective Sleepiness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NapBehavioural

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

Study groups in NCT03333512
Study groupRoleWhat they receive
NapExperimentalAfter each night with a 5-hour sleep opportunity, participants have a daytime nap opportunity of 1.5 hours.
Receives: Behavioral: Nap
No napNo interventionAfter each night with a 6.5-hour sleep opportunity, participants do not have a daytime nap opportunity, but instead watch documentaries.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 3 times daily (10:00, 16:15, and 20:00) for 15 days

  9. Change in blood glucose level, measured using a blood glucose meter, from baseline following the first period sleep restriction, first period of recovery sleep, and second period of sleep restriction

    Score on blood glucose meter

    Measured: Four mornings (after baseline night 2, after sleep restriction night 3 (first sleep restriction period), after recovery night 2 (first recovery period), after sleep restriction night 3 (second sleep restriction period))

  10. Change in meal and snack consumption from baseline following the first period sleep restriction, first period of recovery sleep, and second period of sleep restriction

    Amount of meals and snacks consumed, measured on an ad libitum basis

    Measured: Throughout the 15-day protocol

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

    Score on picture-word association task

    Measured: 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)

  12. Mind-wandering, assessed using a breath-counting task

    Error rate of button presses and percentage of errors that are self-caught

    Measured: Single session, during baseline

  13. Effect of sleep versus wake during delay on the implementation of an intention in the future, where the intention will be encoded either before a 12-hr interval including a night of sleep or a day of wakefulness

    Memory score of correctly remembering to perform the intention following the wake or sleep interval

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

  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 interval

    Measured: 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

    Measured: 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

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

  17. Effect of sleep restriction on problem-solving

    Number of correctly solved equations in matchstick arithmetic task

    Measured: Single session during the 15-day protocol, after sleep restriction night 5 (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

    Measured: 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

    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))

  20. Effect of prior knowledge about the position of items in a previously learned hierarchy on learning of the position of novel items in a new hierarchy

    Percentage of correct responses on the test

    Measured: Single session, during baseline

  21. Effect of sleep restriction on task switching performance

    Difference in reaction time between switch trial and repetition trial in task-switching task

    Measured: Four sessions during the 15-day protocol (after baseline night 1, after sleep restriction night 3 (first sleep restriction period), after recovery night 2 (first recovery period) and after sleep restriction night 3 (second sleep restriction period))

  22. Effect of sleep restriction on attentional bias to threat assessed using visual cues that are coupled either to an aversive sound (threat cue) or a neutral sound (neutral cue)

    Correct responses to a target that is presented at the same (valid) or opposite (invalid) location of stimulus

    Measured: Three session during the 15-day protocol (after baseline night 1, after sleep restriction night 5 (first sleep restriction period), after recovery night 1 (first recovery period))

  23. Effect of verbal reward on procedural memory assessed using a finger tapping task

    Accuracy of performance on the finger-tapping task

    Measured: Two sessions during the 15-day protocol (before baseline night 1 and after baseline night 1)

Secondary outcomes (10)
  1. Change in total sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery

    Total duration of nocturnal sleep was determined to establish baseline sleep characteristics (first and second nights) and changes in the first sleep restriction period (third, fifth and seventh night), the first recovery period (eighth night), the second sleep restriction period (tenth and twelfth night), and the second recovery period (13th night).

    Measured: 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)

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

    Duration of nocturnal N1 sleep was determined to establish baseline sleep characteristics (first and second nights) and changes in the first sleep restriction period (third, fifth and seventh night), the first recovery period (eighth night), the second sleep restriction period (tenth and twelfth night), and the second recovery period (13th night).

    Measured: 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)

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

    Duration of nocturnal N2 sleep was determined to establish baseline sleep characteristics (first and second nights) and changes in the first sleep restriction period (third, fifth and seventh night), the first recovery period (eighth night), the second sleep restriction period (tenth and twelfth night), and the second recovery period (13th night).

    Measured: 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)

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

    Duration of nocturnal N3 sleep was determined to establish baseline sleep characteristics (first and second nights) and changes in the first sleep restriction period (third, fifth and seventh night), the first recovery period (eighth night), the second sleep restriction period (tenth and twelfth night), and the second recovery period (13th night).

    Measured: 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. 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

    Duration of nocturnal REM sleep was determined to establish baseline sleep characteristics (first and second nights) and changes in the first sleep restriction period (third, fifth and seventh night), the first recovery period (eighth night), the second sleep restriction period (tenth and twelfth night), and the second recovery period (13th night).

    Measured: 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)

  6. Change in total sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period

    Total duration of sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (third, fifth and seventh day) to the second sleep restriction period (tenth and twelfth day)

    Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period

  7. Change in N1 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period

    Duration of N1 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (third, fifth and seventh day) to the second sleep restriction period (tenth and twelfth day)

    Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period

  8. Change in N2 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period

    Duration of N2 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (third, fifth and seventh day) to the second sleep restriction period (tenth and twelfth day)

    Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period

  9. Change in N3 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period

    Duration of N3 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (third, fifth and seventh day) to the second sleep restriction period (tenth and twelfth day)

    Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period

  10. Change in REM sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period

    Duration of REM sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (third, fifth and seventh day) to the second sleep restriction period (tenth and twelfth day)

    Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start28 Nov 2017
  3. Primary completion20 Jan 2018
  4. Study completion20 Jan 2018

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03333512
Sponsor's protocol ID
NFS4
Acronym
NFS4
Status last verified
Jan 2018
First submitted
2 Oct 2017
Last updated
1 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38938171
  • 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.

    PubMed 37193393
  • 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.

    PubMed 35089345
  • Lee XK, Chee NIYN, Ong JL, Teo TB, van Rijn E, Lo JC, Chee MWL. Validation of a Consumer Sleep Wearable Device With Actigraphy and Polysomnography in Adolescents Across Sleep Opportunity Manipulations. J Clin Sleep Med. 2019 Sep 15;15(9):1337-1346. doi: 10.5664/jcsm.7932.

    PubMed 31538605
  • Lo JC, Twan DCK, Karamchedu S, Lee XK, Ong JL, Van Rijn E, Gooley JJ, Chee MWL. Differential effects of split and continuous sleep on neurobehavioral function and glucose tolerance in sleep-restricted adolescents. Sleep. 2019 May 1;42(5):zsz037. doi: 10.1093/sleep/zsz037.

    PubMed 30753648

Questions about this trial

What is this clinical trial studying?

A study testing Nap in people with Sleep and Sleep Restriction, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

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 3 inclusion and 5 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 1 Feb 2018. 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 Singapore. 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 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 (time frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03333512, which also lists 5 linked publications.

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 1 Feb 2018.

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