Monitoring Sleep and Glucose Among University Students

September 20, 2024 updated by: Michael W.L. Chee, National University of Singapore
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.

Study Overview

Status

Completed

Conditions

Detailed Description

There are two iterations of this study.

In the first iteration (METWI1), wearables and smartphone-based measures are used to characterise free-living sleep, activity, meal schedules, well-being and continuous glucose profiles in a cohort of healthy, young Chinese university students for 4 weeks during the normal school term. While undergoing glucose monitoring (2 weeks), participants consume a standardised meal plan catered by the laboratory to reduce added variance from dietary intake.

Examining relationships between sleep and behavioural characteristics and glucose profiles may contribute to the identification of phenotypes at higher risk of developing metabolic disorders. Data collected in this study may furthermore aid the identification of changes in sleep patterns associated with closer proximity to academic assessments, when students are predicted to experience increased academic workload and stress. Delays and more irregularity in sleep timing, shorter sleep durations and reduced sleep quality are expected closer to assessment dates. These in turn are predicted to result in higher glucose levels and glycemic variability.

In the second iteration (METWI2), in addition to the above measures, participants undergo an oral glucose tolerance test following a night of moderate sleep restriction and baseline sleep (without sleep restriction). This allows us to examine effects of moderate, at-home sleep restriction on glucose tolerance and insulin sensitivity.

In terms of sleep monitoring, we additionally aim to validate passive WiFi sensing against measurement of sleep using a commercial sleep and activity tracker (Oura ring), smartphone touchscreen interactions (tappigraphy-based sleep estimation) and sleep diary logs in students who are residing in dormitories. Studying this sample affords a convenient, and privacy protecting way of obtaining WiFi data. This can contribute to establishing whether a combination of multiple data sources for sleep detection can improve accuracy of sleep detection, incorporating the influence of device usage in the peri-sleep period. The secondary goal of this sleep study is the triangulation of sleep detection techniques for long term sleep monitoring on university campus. The hope is to access a larger population of students to infer sleep behaviours and sleep health, and eventually, to develop interventions to improve population health using individualised sleep data.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • (No States Listed)
      • Singapore, (No States Listed), Singapore, 117597
        • National University of Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep rectriction
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraindividual changes in sleep duration measured by wearable device (mins) across time
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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.
Time Frame: 1 day
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.
Time Frame: 1 day
We hypothesise that higher insulin resistance will be observed in the sleep restriction condition compared to the baseline sleep condition.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

May 17, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • METWI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Baseline condition

Subscribe