NCT04880629

Brief Summary

This study aims to characterise associations between day-to-day sleep, activity, meal schedules, well-being and continuous glucose profiles in a cohort of free-living healthy, young adults. Multi-day data will be collected using wearables and smartphone-based measures in field settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2021

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

May 5, 2021

Last Update Submit

September 20, 2024

Conditions

Keywords

GlucoseInsulin

Outcome Measures

Primary Outcomes (16)

  • Intraindividual changes in sleep duration measured by wearable device (mins) across time

    We hypothesise that participants will exhibit shorter sleep durations on nights in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in sleep timing measured by wearable device (mins) across time

    We hypothesise that participants will exhibit later sleep timings on nights in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in sleep regularity measured by wearable device (mins) across time

    We hypothesise that participants will exhibit less regular sleep timings on nights in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in nap behaviour measured by self-report and wearable device (mins) across time

    We hypothesise that participants will exhibit more polyphasic sleep schedules (more nap episodes) in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in daily self-reported stress across time

    We hypothesise that participants will report higher levels of stress in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in daily self-reported sleep quality across time

    We hypothesise that participants will report poorer sleep quality in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in daily self-reported mood across time

    We hypothesise that participants will report more negative mood reports in closer proximity to exam dates.

    4 weeks

  • Intraindividual changes in glucose values across time

    We hypothesise that mean daily, diurnal, nocturnal, and postprandial glucose values will be higher, and that 24-h glucose will be more variable in closer proximity to exam dates, and that these will be associated with the extent of sleep pattern alteration experienced by participants.

    4 weeks

  • Intraindividual changes in average glucose across time

    We hypothesise that average daily glucose values will be higher in closer proximity to exam dates, and that these changes will be associated with the extent of sleep pattern alteration experienced by participants.

    4 weeks

  • Intraindividual changes in glycemic variability across time

    We hypothesise that daily glucose values will be more variable in closer proximity to exam dates, and that these changes will be associated with the extent of sleep pattern alteration experienced by participants.

    4 weeks

  • Intraindividual changes in postprandial glucose across time

    We hypothesise that average postprandial change in glucose will be higher in closer proximity to exam dates, and that these changes will be associated with the extent of sleep pattern alteration experienced by participants.

    4 weeks

  • Differences in average glucose between individuals with habitually different sleep profiles

    We expect to observe higher daily average glucose among individuals who habitually obtain less sleep and have greater irregularity in sleeping patterns, compared to individuals who obtain more sleep and have more regular sleeping patterns

    4 weeks

  • Differences in glycemic variability between individuals with habitually different sleep profiles

    We expect to observe more variable daily glucose values among individuals who habitually obtain less sleep and have greater irregularity in sleeping patterns, compared to individuals who obtain more sleep and have more regular sleeping patterns

    4 weeks

  • Accuracy of sleep detection using multiple data sources

    We hypothesise that sleep detection accuracy will increase when wearable, WIFI and smartphone-based data sources are combined.

    4 weeks

  • Effect of sleep restriction condition on glucose tolerance measured by oral glucose tolerance test.

    We hypothesise that higher glucose tolerance will be observed in the sleep restriction condition compared to the baseline sleep condition.

    1 day

  • Effect of sleep restriction condition on insulin resistance measured by oral glucose tolerance test.

    We hypothesise that higher insulin resistance will be observed in the sleep restriction condition compared to the baseline sleep condition.

    1 day

Study Arms (1)

Sleep rectriction

EXPERIMENTAL

Participants in METWI2 undergo both a baseline (unrestricted) sleep and sleep restriction condition. On the morning following each condition, participants complete an oral glucose tolerance test to measure changes in glucose and insulin following ingestion of a glucose load.

Behavioral: Baseline conditionBehavioral: Sleep restriction condition

Interventions

In the baseline sleep condition, participants are instructed not to restrict their sleep on the night before completing an oral glucose tolerance test (OGTT). Participants are prescribed sleep-wake timings based on their preferred and averaged sleep durations measured over 2 weeks using a wearable sleep tracker. Sleep timings and durations on the 3 nights before the OGTT are verified using a sleep diary and sleep tracker.

Sleep rectriction

In the sleep restriction condition, participants are prescribed sleep timings to restrict their sleep by 1 to 2 hours on the night before completing an oral glucose tolerance test (OGTT). Sleep timings and durations on the 3 nights before the OGTT are verified using a sleep diary and sleep tracker.

Sleep rectriction

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese
  • NUS student residing on campus during semester
  • Healthy
  • No sleeping disorders/eating disorders/neurological illnesses
  • BMI between 18.0 and 24.9

You may not qualify if:

  • Smoker
  • Pregnant
  • Dietary restrictions
  • Not able to collect meals and adhere to provided meal plan, or habitual meals/mealtimes from 3-day food diary deemed unsuitable for provided meal plan
  • Moderate to severe depression/anxiety scores from BDI or BAI respectively
  • Impaired glucose tolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, (No States Listed), 117597, Singapore

Location

Related Publications (2)

  • Ng ASC, Tai ES, Chee MWL. Effects of night-to-night variations in objectively measured sleep on blood glucose in healthy university students. Sleep. 2025 Feb 10;48(2):zsae224. doi: 10.1093/sleep/zsae224.

  • Ng ASC, Massar SAA, Bei B, Chee MWL. Assessing 'readiness' by tracking fluctuations in daily sleep duration and their effects on daily mood, motivation, and sleepiness. Sleep Med. 2023 Dec;112:30-38. doi: 10.1016/j.sleep.2023.09.028. Epub 2023 Sep 28.

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigatore, Professor

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 11, 2021

Study Start

March 3, 2021

Primary Completion

May 17, 2021

Study Completion

December 31, 2023

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations