- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02838095
Effects of Napping in Sleep-Restricted Adolescents
Effectiveness of a Daytime Nap on Alleviating Cognitive Impairment Due to Short Sleep in Adolescents
Study Overview
Detailed Description
57 participants (aged 15 to 19 years old) were grouped into nap and no nap groups. Both groups took part in a 15-day protocol that started with 2 9-hour adaptation and baseline nights, followed by two successive cycles of sleep restriction (5-h time-in-bed [TIB]; 01:00-06:00) and recovery (9-h TIB; 23:00-08:00) intended to simulate the weekday sleep loss and weekend attempt to 'catch up' that are familiar to high school students. The nap group received a 1-hour nap opportunity at 14:00 following each sleep-restricted night, while participants in the no nap group watched a documentary. Sleep was monitored with polysomnography on 9 selected nights. Cognitive performance, subjective sleepiness, and mood were assessed 3 times daily (10:00, 15:45, and 20:00).
All participants stayed in air-conditioned, twin-share bedrooms with en-suite bathrooms. Bedroom windows were fitted with blackout panels to ensure participants were not woken up prematurely by sunlight. Earplugs were also provided, and participants were allowed to adjust the temperature of their bedrooms to their personal comfort. 3 main meals were served each day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and strenuous physical activities were prohibited.
Outside of scheduled sleep, meal, and cognitive testing times, participants spent the majority of their free time in a common room that was illuminated by natural and artificial lighting. They were allowed to read, play non-physically exerting games, watch videos, and interact with research staff and other participants. Participants were under constant supervision by the research staff.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 169857
- Duke-NUS Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: No nap
After each night with a 5-hour sleep opportunity, participants did not have a daytime nap opportunity, but instead watched documentaries.
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EXPERIMENTAL: Nap
After each night with a 5-hour sleep opportunity, participants had the chance to take a daytime nap from 14:00 to 15:00.
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A 1-hour daytime nap opportunity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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, 15:45, and 20:00) for 15 days
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Number of attention lapses (>500ms)
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Number of correct responses in the 1-back task
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Number of correct responses in the 3-back task
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Score on the Karolinska Sleepiness Scale (1-9 points)
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Total score on the positive subscale of the PANAS
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Total score on the negative subscale of the PANAS
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Number of correct responses in the task
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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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, 15:45, and 20:00) for 15 days
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Number of correct responses in the task
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3 times daily (10:00, 15:45, and 20:00) for 15 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
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Total duration of nocturnal sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
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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)
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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 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
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Duration of nocturnal N1 sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
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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)
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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 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
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Duration of nocturnal N2 sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
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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)
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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 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
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Duration of nocturnal N3 sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
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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)
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Change in 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 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
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Duration of nocturnal REM sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
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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)
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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)
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Total duration of sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
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Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
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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)
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Duration of N1 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
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Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
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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)
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Duration of N2 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
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Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
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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)
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Duration of N3 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
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Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
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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)
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Duration of REM sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
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Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFS2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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