Sleep Clinical Trial
— NFS4Official title:
The Cognitive and Metabolic Effects of Sleep Restriction in Adolescents
Verified date | January 2018 |
Source | Duke-NUS Graduate Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Duke-NUS Medical School | Singapore |
Lead Sponsor | Collaborator |
---|---|
Duke-NUS Graduate Medical School | National Medical Research Council (NMRC), Singapore |
Singapore,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT04513743 -
Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ
|
N/A | |
Completed |
NCT03251274 -
Bath Machine on Sleep Quality in Nursing Home
|
N/A | |
Completed |
NCT04102345 -
Lavender vs Zolpidem Sleep Quality During Diagnostic PSG
|
Early Phase 1 | |
Completed |
NCT03725943 -
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults
|
N/A | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT04562181 -
Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index
|
N/A | |
Completed |
NCT05576844 -
Ai Youmian (Love Better Sleep) for People Living With HIV
|
N/A | |
Completed |
NCT05102565 -
A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers
|
N/A | |
Completed |
NCT04688099 -
Synovial Fluid Sleep Study
|
||
Recruiting |
NCT04171245 -
Prescribing Laughter for Sleep and Wellbeing in UAE University Students
|
N/A | |
Completed |
NCT03758768 -
The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms
|
N/A | |
Completed |
NCT03163498 -
Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
|
||
Completed |
NCT04093271 -
Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
|
Phase 1 | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT04120363 -
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
|
Phase 4 |