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临床试验/NCT04731662
NCT04731662已完成不适用

Effects of Recurrent Short and Variable Sleep on Cognitive Performance, Brain Dynamics, Psychological Well-being, and Glucose Metabolism

National University of Singapore1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Effect of variable sleep on picture encoding response time

研究概览

简要总结

This proposed project will investigate whether a variable or a stable sleep schedule will be more effective in minimizing neurobehavioural and metabolic deficits when total sleep opportunity across two weeks is below the recommended sleep duration. In this laboratory-based, stay-in study, 60 young adults will be randomized into 1 of 3 groups. After 2 nights of 8-h time-in-bed (TIB) that simulate longer sleep opportunities typical of weekends, the stable short sleep group will have a 6-h TIB in each of the following 5 'weeknights' (8866666). The variable short sleep group (8884846) will also have a total TIB of 30h during the 'weeknights', although TIB varies across the 'weeknights'. The nightly TIB of the well-rested control group will be 8h (8888888). These manipulations will repeat in the second week, enabling the tracking of outcome measures during recurrent weeks of sleep restriction on 'weekdays' and extension on 'weekends'. A test battery assessing basic cognitive functions and mood will be administered 5 times a day. A long-term memory encoding task will be administered after week 1. A functional Magnetic Resonance Imaging (fMRI) brain scan, and an Oral Glucose Tolerance Test (OGTT) will be conducted after the second 'weekend' night and after the last 'weeknight' each week. Continuous glucose monitoring will be conducted throughout the experiment. Sleep will be measured every night with polysomnography.

详细描述

This proposed project will investigate whether a variable or a stable sleep schedule will be more effective in minimizing neurobehavioural and metabolic deficits when total sleep opportunity across two weeks is below the recommended sleep duration. This project involves young adults aged 21 - 35. For the two weeks leading up to the stay-in study, participants' sleep-wake patterns will be assessed via actigraphy and sleep diary. For the first week, participants will be asked to follow their habitual sleep schedule, while in the following week, the participants will be instructed to follow a specific sleep schedule with an 8-h sleep opportunity each night during the 7-night period with no napping allowed.

After the two weeks of actigraphy, participants will begin the 16-day in-lab protocol. Participants will be randomised into 1 of 3 groups. All the participants will have an 8-h sleep opportunity during the first two nights (baseline nights) that simulate longer sleep opportunities typical of weekends. During the next 5 'weeknights', the participant's sleep opportunities will be manipulated depending on their assigned group. The stable short sleep group will have a 6-h TIB in each of the following 5 'weeknights' (8866666). The variable short sleep group (8884846) will also have a total TIB of 30h during the 'weeknights', although TIB varies across the 'weeknights'. The nightly TIB of the well-rested control group will be 8h (8888888). The same sleep schedules will be implemented in the second week. The protocol will end with an 8-h sleep opportunity on night 15. For each participant, wake times will remain the same (i.e., participant's own habitual wake time derived from self-report and actigraphy) for all the TIBs. Thus, bedtimes will be delayed progressively with decreasing TIBs for the short sleep groups.

A battery of cognitive tests and psychological scales (approximately 30 minutes) will be administered 5 times a day at 3-hourly intervals, starting from 1.5 hours since awakening.

A memory encoding task will be administered on Day 8 to determine whether a variable/stable short sleep schedule is less disruptive to the acquisition of long-term memory. During the task, participants will be presented with 160 images containing a stimulus (e.g. landscapes) or no stimulus on a computer screen. Each image will be displayed for 2500ms followed by a response screen to prompt participants to indicate if a stimulus was previously presented. On Day 10, a randomized set of 240 images consisting of the 160 images previously shown (i.e. "old" images) and 80 "new" images will be presented to participants. Participants are tested on their recognition of the "old images" by selecting on a 5-point scale: (1) definitely did not see, (2) probably did not see), (3) unsure, (4) probably saw, (5) definitely saw. The two tasks will take approximately 25 minutes each.

An OGTT and fMRI brain scan will be performed after the second baseline night 2 (Day 3) and the last 'weeknight' each week (Day 8 and 15). Participants will be asked to perform 8 hours of overnight fasting before each OGTT. On the morning of the OGTT, an intravenous catheter will be inserted into the forearm of participants. Thereafter, 6 mL of blood samples will be drawn in a lying/sitting position. Participants will then be given a 75-g glucose solution to finish drinking within 7-10mins. 6 mL of blood samples will be collected again at time 15, 30, 60, and 120 minutes to measure for changes in glucose and insulin levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •21-35 years of age
  • •BMI between 18.5 and 24.9
  • •Not habitual short sleepers
  • •Not extreme chronotypes
  • •Not a shift worker
  • •Not a smoker
  • •Daily consumption of ≤ 5 cups of caffeinated beverages
  • •Weekly consumption of ≤ 14 units of alcohol
  • •Do not intend to travel across > 2 time zones 1 month prior to the experiment
  • •Not a fussy eater
  • •Do not have any food allergy
  • •No strict dietary requirements
  • •No intention to lose or gain weight in the next 6 months
  • •Not pregnant during the study
  • •Do not have any metallic implants
  • •Do not suffer from claustrophobia (last three inclusion criteria are only applicable for fMRI)

排除标准

  • •The reverse of the inclusion criteria

研究组 & 干预措施

Control Group (8888888)

No Intervention

The Control group will have 8-hours time-in-bed, both weeknights and weekends.

Stable Short Sleep (8866666)

Experimental

The short sleep group will have 6-hours time-in-bed on weeknights and 8-hours time-in-bed on weekends.

干预措施: Short sleep (Behavioral)

Variable short sleep group (8884846)

Experimental

The short sleep group time in-bed will vary across weeknights but will maintain the same amount of total time-in bed as the stable short sleep (8866666).

干预措施: Variable short sleep (Behavioral)

结局指标

主要结局

Effect of variable sleep on picture encoding response time

时间窗: Single session (Day 8)

Mean response time

Change in discriminability measure (A') assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Discriminability measure (A')

Change in median reaction time 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

时间窗: 5 times daily for 16 days

Median reaction time

Change in number of incorrect matches assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of incorrect matches in the 1-back task

Change in number of correct matches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of correct matches in the 3-back task

Change in number of correct mismatches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of correct mismatches in the 3-back task

Change in number of incorrect matches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of incorrect matches in the 3-back task

Change in standard deviation in reaction time of sleep restriction and recovery

时间窗: 5 times daily for 16 days

Standard deviation in reaction time

Change in number of correct matches assessed with the 1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of correct matches in the 1-back task

Change in incorrect mismatches assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of incorrect mismatches in the 1-back task

Change in discriminability measure (A') assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Discriminability measure (A')

Change in speed of processing assessed with the Symbol Digit Modalities Test from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily (09:00, 12:00, 15:00, 18:00, 21:00) for 16 days

Number of correct responses in the task

Change in number of commission errors / false starts 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

时间窗: 5 times daily for 16 days

Number of commission errors / false starts

Change in bias measure (B"D) assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Bias measure (B"D)

Change in number of incorrect mismatches assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of incorrect mismatches in the 3-back task

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 manipulation and recovery

时间窗: 5 times daily for 16 days

Total score on the negative subscale of the PANAS

Change in the level of anxiety symptomatology from the mornings of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle.

时间窗: 3 separate days (Day 3, 8 and 15)

Score on the Mood and Anxiety Symptom Questionnaire (Scale 1-5)

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

时间窗: 5 times daily for 16 days

Number of attention lapses (\>500ms)

Change in mean reaction time 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

时间窗: 5 times daily for 16 days

Mean reaction time

Change in number of correct mismatches assessed with the1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Number of correct mismatches in the 1-back task

Change in bias measure (B"D) assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Bias measure (B"D)

Change in the level of subjective sleepiness assessed with the Karolinska Sleepiness Scale from morning to afternoon then evening from baseline days to the first and second cycle of sleep manipulation and recovery

时间窗: 5 times daily for 16 days

Score on the Karolinska Sleepiness Scale (1-9 points)

Change in the level of depressive symptomatology from the mornings of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle.

时间窗: 3 separate days (Day 3, 8 and 15)

Score on the Mood and Anxiety Symptom Questionnaire (Scale 1-5)

Changes in interstitial fluid glucose levels from morning to afternoon then evening from baseline days to the first and second cycles of sleep manipulation and recovery.

时间窗: All 16-days with 8-hour interval readings

Area under the curve for interstitial fluid glucose

Effect of variable sleep on picture recognition response time

时间窗: Single session (Day 10)

Mean response time

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 manipulation and recovery

时间窗: 5 times daily for 16 days

Total score on the positive subscale of the PANAS

Change in the level of satisfaction with life from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily (09:00, 12:00, 15:00, 18:00, 21:00) for 16 days

Score on the Satisfaction with Life Scale (1-7 scale)

Changes in the task related brain functional connectivity from the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle.

时间窗: 3 days (Day 3, 8, 15)

Brain functional connectivity in fMRI analysis

Effect of variable sleep on picture recognition hit rate

时间窗: Single session (Day 10)

Hit rate

Change in speed of processing assessed with the Mental Arithmetic Test (MAT) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep manipulation and recovery

时间窗: 5 times daily (09:00, 12:00, 15:00, 18:00, 21:00) for 16 days

Number of correct response in the task

Changes in the blood glucose levels from morning of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle.

时间窗: 3 days (Day 3, 8 and 15) 6mL blood sample collection at 15, 30, 60, and 120 minutes

Area under the curve for plasma glucose

Changes in the insulin levels from morning of the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle.

时间窗: 3 days (Day 3, 8 and 15) 6mL blood sample collection at 15, 30, 60, and 120 minutes

Area under the curve for insulin

Changes in the resting-state brain functional connectivity from the second baseline day to the last day of the first sleep manipulation cycle and the last day of the second sleep manipulation cycle.

时间窗: 3 days (Day 3, 8, 15)

Brain functional connectivity in fMRI analysis

Effect of variable sleep on picture encoding response accuracy

时间窗: Single session (Day 8)

Response accuracy

Effect of variable sleep on picture recognition false alarm rate

时间窗: Single session (Day 10)

False alarm rate

Effect of variable sleep on picture recognition discriminability measure (A')

时间窗: Single session (Day 10)

Discriminability measure (A')

次要结局

  • Change in total sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N1 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in the Rapid Eye Movement (REM) sleep duration at night with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change sleep efficiency at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N2 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N3 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N3 sleep percentage at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in wake after sleep onset duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N1 sleep percentage at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change slow wave activity/ slow wave energy at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N2 sleep percentage at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in N2 sleep latency at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change spindle activity at night assessed with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))
  • Change in the Rapid Eye Movement (REM) sleep percentage at night with polysomnography from baseline nights to the first and second cycles of sleep manipulation and recovery(Nocturnal sleep on nights 1 & 2 (baseline), 3, 4, 5, 6 & 7 (first sleep manipulation period), 8 & 9 (first recovery period), 10,11,12, 13, 14 (second sleep manipulation period), & 15 (second recovery period))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

June Chi Yan Lo

Principal Investigator, Assistant Professor

National University of Singapore

研究点 (1)

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