NCT04731662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

January 26, 2021

Last Update Submit

November 12, 2024

Conditions

Keywords

Glucose MetabolismfMRISubjective SleepinessNeurobehavioral FunctionsCognitive FunctionsSleep Variability

Outcome Measures

Primary Outcomes (36)

  • 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)

    5 times daily for 16 days

  • 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

    Mean reaction time

    5 times daily for 16 days

  • 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

    Median reaction time

    5 times daily for 16 days

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

    Standard deviation in reaction time

    5 times daily for 16 days

  • 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

    Number of commission errors / false starts

    5 times daily for 16 days

  • 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

    Number of correct matches in the 1-back task

    5 times daily for 16 days

  • 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

    Number of correct mismatches in the 1-back task

    5 times daily for 16 days

  • 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

    Number of incorrect matches in the 1-back task

    5 times daily for 16 days

  • 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

    Number of incorrect mismatches in the 1-back task

    5 times daily for 16 days

  • 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

    Discriminability measure (A')

    5 times daily for 16 days

  • 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

    Bias measure (B"D)

    5 times daily for 16 days

  • 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

    Number of correct matches in the 3-back task

    5 times daily for 16 days

  • 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

    Number of correct mismatches in the 3-back task

    5 times daily for 16 days

  • 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

    Number of incorrect matches in the 3-back task

    5 times daily for 16 days

  • 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

    Number of incorrect mismatches in the 3-back task

    5 times daily for 16 days

  • 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

    Discriminability measure (A')

    5 times daily for 16 days

  • 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

    Bias measure (B"D)

    5 times daily for 16 days

  • 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

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

    5 times daily for 16 days

  • 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

    Total score on the positive subscale of the PANAS

    5 times daily for 16 days

  • 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

    Total score on the negative subscale of the PANAS

    5 times daily for 16 days

  • 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.

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

    3 separate days (Day 3, 8 and 15)

  • 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.

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

    3 separate days (Day 3, 8 and 15)

  • 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

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

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

  • 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

    Number of correct response in the task

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

  • 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

    Number of correct responses in the task

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

  • 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.

    Area under the curve for plasma glucose

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

  • 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.

    Area under the curve for insulin

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

  • 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.

    Area under the curve for interstitial fluid glucose

    All 16-days with 8-hour interval readings

  • 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.

    Brain functional connectivity in fMRI analysis

    3 days (Day 3, 8, 15)

  • 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.

    Brain functional connectivity in fMRI analysis

    3 days (Day 3, 8, 15)

  • Effect of variable sleep on picture encoding response time

    Mean response time

    Single session (Day 8)

  • Effect of variable sleep on picture encoding response accuracy

    Response accuracy

    Single session (Day 8)

  • Effect of variable sleep on picture recognition response time

    Mean response time

    Single session (Day 10)

  • Effect of variable sleep on picture recognition hit rate

    Hit rate

    Single session (Day 10)

  • Effect of variable sleep on picture recognition false alarm rate

    False alarm rate

    Single session (Day 10)

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

    Discriminability measure (A')

    Single session (Day 10)

Secondary Outcomes (14)

  • 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 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 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 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 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)

  • +9 more secondary outcomes

Study Arms (3)

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.

Behavioral: Short sleep

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).

Behavioral: Variable short sleep

Interventions

Short sleepBEHAVIORAL

6-hours time-in-bed during weeknights

Stable Short Sleep (8866666)

Variable hours of time-in bed during weeknights

Variable short sleep group (8884846)

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Healthy
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD 11- NUS Yong Loo Lin School of Medicine

Singapore, Singapore, 117597, Singapore

Location

Related Publications (3)

  • Cheung YYY, Tan TYL, Koa TB, Khoo CM, Lo JC. Glucose homeostasis during recurrent periods of sleep restriction and recovery in healthy young adults. Sleep. 2025 Oct 30:zsaf339. doi: 10.1093/sleep/zsaf339. Online ahead of print.

  • Koa TB, Ong JL, Lo JC. Changes in sleep architecture during recurrent cycles of sleep restriction: a comparison between stable and variable short sleep schedules. Sleep Adv. 2025 Mar 15;6(2):zpaf016. doi: 10.1093/sleepadvances/zpaf016. eCollection 2025 Apr.

  • Koa TB, Gooley JJ, Chee MWL, Lo JC. Neurobehavioral functions during recurrent periods of sleep restriction: effects of intra-individual variability in sleep duration. Sleep. 2024 Mar 11;47(3):zsae010. doi: 10.1093/sleep/zsae010.

Study Officials

  • June Chi Yan Lo

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

February 1, 2021

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations