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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333512
Other study ID # NFS4
Secondary ID
Status Completed
Phase N/A
First received October 2, 2017
Last updated January 31, 2018
Start date November 28, 2017
Est. completion date January 20, 2018

Study information

Verified date January 2018
Source Duke-NUS Graduate Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date January 20, 2018
Est. primary completion date January 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 19 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Singapore Duke-NUS Medical School Singapore

Sponsors (2)

Lead Sponsor Collaborator
Duke-NUS Graduate Medical School National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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))
Primary 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 Throughout the 15-day protocol
Primary 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)
Primary Mind-wandering, assessed using a breath-counting task Error rate of button presses and percentage of errors that are self-caught Single session, during baseline
Primary 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 Single session during the 15-day protocol, after baseline night 1 or before sleep restriction night 1 (first sleep restriction period)
Primary 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 Single session during the 15-day protocol, after baseline night 1 or before sleep restriction night 1 (first sleep restriction period)
Primary 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)
Primary 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)
Primary Effect of sleep restriction on problem-solving Number of correctly solved equations in matchstick arithmetic task Single session during the 15-day protocol, after sleep restriction night 5 (first sleep restriction period)
Primary 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)
Primary 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))
Primary 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 Single session, during baseline
Primary Effect of sleep restriction on task switching performance Difference in reaction time between switch trial and repetition trial in task-switching task 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))
Primary 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 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))
Primary Effect of verbal reward on procedural memory assessed using a finger tapping task Accuracy of performance on the finger-tapping task Two sessions during the 15-day protocol (before baseline night 1 and after baseline night 1)
Secondary 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). 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)
Secondary 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). 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)
Secondary 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). 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)
Secondary 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). 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)
Secondary 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). 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)
Secondary 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) Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
Secondary 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) Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
Secondary 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) Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
Secondary 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) Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
Secondary 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) Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
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