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The Cognitive and Metabolic Effects of Sleep Restriction in Adolescents (NFS4)

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ClinicalTrials.gov Identifier: NCT03333512
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Michael WL Chee, MBBS, Duke-NUS Graduate Medical School

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sleep Sleep Restriction Behavioral: Nap Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Cognitive and Metabolic Effects of Sleep Restriction in Adolescents
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : January 20, 2018

Arm Intervention/treatment
Experimental: Nap
After each night with a 5-hour sleep opportunity, participants have a daytime nap opportunity of 1.5 hours.
Behavioral: Nap
Looking at the difference between continuous sleep opportunities and split-sleep opportunities.

No Intervention: No nap
After each night with a 6.5-hour sleep opportunity, participants do not have a daytime nap opportunity, but instead watch documentaries.



Primary Outcome Measures :
  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Number of attention lapses (>500ms)

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Number of correct responses in the 1-back task

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Number of correct responses in the 3-back task

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Score on the Karolinska Sleepiness Scale (1-9 points)

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Total score on the positive subscale of the PANAS

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Total score on the negative subscale of the PANAS

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Number of correct responses in the task

  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 [ Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days ]
    Number of correct responses in the task

  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 [ Time Frame: 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)) ]
    Score on blood glucose meter

  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 [ Time Frame: Throughout the 15-day protocol ]
    Amount of meals and snacks consumed, measured on an ad libitum basis

  11. Change in memory performance in picture-word association task over sleep restriction nights and recovery night [ Time Frame: 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) ]
    Score on picture-word association task

  12. Mind-wandering, assessed using a breath-counting task [ Time Frame: Single session, during baseline ]
    Error rate of button presses and percentage of errors that are self-caught

  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 [ Time Frame: Single session during the 15-day protocol, after baseline night 1 or before sleep restriction night 1 (first sleep restriction period) ]
    Memory score of correctly remembering to perform the intention following the wake or sleep interval

  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 [ Time Frame: Single session during the 15-day protocol, after baseline night 1 or before sleep restriction night 1 (first sleep restriction period) ]
    Memory score of correctly remembered encoded pictures following the wake or sleep interval

  15. Effect of sleep restriction on learning of novel material (about different animal species) across separate sessions [ Time Frame: Single session during the 15-day protocol, after recovery night 2 (first recovery period) ]
    Memory score on test of learned material

  16. Effect of sleep restriction on memory of spatial locations [ Time Frame: Single session during the 15-day protocol, after sleep restriction night 3 (first sleep restriction period) ]
    Performance in four mountains task

  17. Effect of sleep restriction on problem-solving [ Time Frame: Single session during the 15-day protocol, after sleep restriction night 5 (first sleep restriction period) ]
    Number of correctly solved equations in matchstick arithmetic task

  18. Effect of sleep restriction on picture encoding [ Time Frame: Single session during the 15-day protocol, after recovery night 2 (second recovery period) ]
    Memory score of correctly remembered encoded pictures of non-famous people, landscapes, scenes and objects

  19. Effect of sleep restriction on effort/temporal discounting [ Time Frame: 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)) ]
    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

  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 [ Time Frame: Single session, during baseline ]
    Percentage of correct responses on the test

  21. Effect of sleep restriction on task switching performance [ Time Frame: 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)) ]
    Difference in reaction time between switch trial and repetition trial in task-switching task

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

  23. Effect of verbal reward on procedural memory assessed using a finger tapping task [ Time Frame: Two sessions during the 15-day protocol (before baseline night 1 and after baseline night 1) ]
    Accuracy of performance on the finger-tapping task


Secondary Outcome Measures :
  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 [ Time Frame: 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) ]
    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).

  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 [ Time Frame: 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) ]
    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).

  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 [ Time Frame: 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) ]
    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).

  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 [ Time Frame: 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) ]
    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).

  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 [ Time Frame: 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) ]
    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).

  6. Change in total sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period [ Time Frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (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)

  7. Change in N1 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period [ Time Frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (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)

  8. Change in N2 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period [ Time Frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (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)

  9. Change in N3 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period [ Time Frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (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)

  10. Change in REM sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period [ Time Frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (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)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333512


Locations
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Singapore
Duke-NUS Medical School
Singapore, Singapore, 169857
Sponsors and Collaborators
Duke-NUS Graduate Medical School
National Medical Research Council (NMRC), Singapore
Investigators
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Principal Investigator: Michael WL Chee, MBBS Duke-NUS Graduate Medical School
  Study Documents (Full-Text)

Documents provided by Michael WL Chee, MBBS, Duke-NUS Graduate Medical School:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael WL Chee, MBBS, Principal Investigator, Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT03333512     History of Changes
Other Study ID Numbers: NFS4
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael WL Chee, MBBS, Duke-NUS Graduate Medical School:
Nap
Recovery Sleep
Cognitive Functions
Glucose Metabolism
Neurobehavioral Functions
Mood
Subjective Sleepiness