- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04044885
Investigating Preferred Nap Schedules for Adolescents (NFS5)
Investigating the Preferred Nap Schedule for Adolescents With Adequate Sleep
Study Overview
Detailed Description
The present study investigates whether a continuous stretch of night time sleep (8 hours) will lead to better neurobehavioural outcomes relative to nocturnal sleep restriction (6.5 hours) and daytime nap (1.5 hours) of the same total duration. 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 (6.5-h time in bed (TIB); 00:15-06:45 or 8-h TIB; 23:30-07:30) 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).
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 169857
- Duke-NUS Medical School
-
-
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nap
After each night with a 6.5-hour sleep opportunity, participants have a daytime nap opportunity of 1.5 hours.
|
Looking at the difference between continuous sleep opportunities and split-sleep opportunities.
|
|
No Intervention: No nap
After each night with a 8-hour sleep opportunity, participants do not have a daytime nap opportunity, but instead have free time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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 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
Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days
|
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
Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days
|
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
Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days
|
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
Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days
|
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
Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days
|
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
Time Frame: 3 times daily (10:00, 16:15, and 20:00) for 15 days
|
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
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 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
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
|
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
Time Frame: Single session during the 15-day protocol, after recovery night 2 (first recovery period)
|
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
Time Frame: Single session during the 15-day protocol, after sleep restriction night 3 (first sleep restriction period)
|
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
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
|
Single session during the 15-day protocol, after recovery night 2 (second recovery period)
|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
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).
|
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
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).
|
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
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).
|
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
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).
|
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 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)
|
Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
|
|
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)
|
Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
|
|
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)
|
Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
|
|
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)
|
Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
|
|
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)
|
Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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. Erratum In: Sleep. 2021 Jul 9;44(7):
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NFS5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
-
Hospital Felicio RochoNot yet recruitingSleep Apnea/Hypopnea Syndrome | Sleep Apnea Syndrome, Obstructive | Sleep Apnea Syndrome (OSAS) | Sleep Apnea - Obstructive
Clinical Trials on Nap
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingShift WorkUnited States
-
Brigham and Women's HospitalTerminatedSleep Disorders, Intrinsic | Sleep Disorders, Circadian Rhythm | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase Syndrome | Shift-Work Sleep Disorder | Delayed Sleep Phase | Non-24 Hour Sleep-Wake Disorder | Advanced Sleep Phase Syndrome | Advanced Sleep Phase | Irregular Sleep-Wake Syndrome | Shift...United States
-
University of Maryland, College ParkUniversity of Massachusetts, AmherstRecruiting
-
Duke-NUS Graduate Medical SchoolNational Medical Research Council (NMRC), SingaporeCompleted
-
Kessler FoundationRecruitingTraumatic Brain InjuryUnited States
-
University Hospital, CaenCompleted
-
Centre Hospitalier Departemental VendeeCompleted
-
The University of Hong KongChinese University of Hong KongCompleted
-
Duke-NUS Graduate Medical SchoolNational Medical Research Council (NMRC), SingaporeCompletedSleep | Sleep RestrictionSingapore
-
Xinhua Hospital, Shanghai Jiao Tong University...Not yet recruiting