- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695235
Monitoring Sleep, Wellbeing, and Glucose Metabolism in PGY1s
Monitoring Sleep, Wellbeing, and Glucose Metabolism in Postgraduate Year 1 Doctors on Traditional and Float Call Shifts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overnight on-call schedules can impact sleep, wellbeing, and alertness, which can be detrimental on the performance, physical and mental health of residents. Moreover, rotating shift work may have a long-term negative health impact (e.g. increased risk of diabetes). Within the National University Hospital (NUH), two different systems of rotating on-call schedules are implemented. In the night float system, residents work from 8 pm to 8 am for 5 - 7 consecutive nights once every month, compared to the traditional overnight on-call system, where each resident is on call for 4-6 nights per month (7 am - 5 pm, followed by overnight call until 8 am the next morning). The aim of the current study is to track sleep, wellbeing, and glucose metabolism during the different phases of the night float and traditional on-call schedules.
The availability of accurate mobile methodologies to monitor sleep and metabolic health provide new avenues for the improvement of sleep health and well-being. Wearable sleep tracking devices and smartphone apps provide remarkable opportunities for non-invasive, longitudinal sleep detection. Measurement of sleep during different stages of the shift schedule (baseline, on-call, recovery) can provide detailed insights into the temporal impact of the different schedules. Moreover, self-reported ratings of sleep quality, wellbeing, and time-use (delivered through phone-based e-diary methods) can further detail the mental health impact associated with these schedules.
Wearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stijn Agus Adrianus Massar, PhD
- Phone Number: +65 66015238
- Email: mdcsaam@nus.edu.sg
Study Locations
-
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(No States Listed)
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Singapore, (No States Listed), Singapore, 117597
- Recruiting
- National University of Singapore
-
Contact:
- Michael WL Chee, MBBS
- Phone Number: +65 65164916
- Email: michael.chee@nus.edu.sg
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Contact:
- Alyssa Ng
- Phone Number: +6584044909
- Email: alyssa.ng@u.nus.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- NUHS Postgraduate year 1 doctors
- Above 21 years of age
- Completing their year 1 rotations in 2021 or 2022
Exclusion Criteria:
- As this is an observational study with minimal risk, in an restricted pool of participants, no further exclusion criteria will be applied for participation.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traditional call
In the traditional overnight on-call system, each resident is on call for 4-6 nights per month (7 am - 5 pm, followed by overnight call until 8 am the next morning)
|
Wearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.
Wearable sleep tracking device
Participants will be prompted daily to fill out a short set of wellbeing questions and perform a short alertness test on their mobile phones and laptop.
|
Float call
In the night float system, residents work from 8 pm to 8 am for 5 - 7 consecutive nights once every month
|
Wearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.
Wearable sleep tracking device
Participants will be prompted daily to fill out a short set of wellbeing questions and perform a short alertness test on their mobile phones and laptop.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep
Time Frame: 8 weeks
|
Sleep duration and timing will be measured
|
8 weeks
|
Glucose monitoring
Time Frame: 2 weeks
|
Blood glucose will be recorded using a wearable continuous glucose monitoring sensor (CGM: FreeStyle Libre Pro iQ by Abbott).
CGM period will be individually scheduled to coincide with at least one cycle of day shift-night shift- recovery for each participant.
|
2 weeks
|
Wellbeing
Time Frame: 8 weeks
|
Participants will complete a daily micro questionnaire delivered through a mobile phone-based application.
The investigators will examine mood ratings and stress ratings.
Participants will be asked to respond to questions such as "How are you feeling right now?", rating their response from 'Negative' to 'Positive' on a 100-points sliding bar, "How stressed are you feeling right now?", rating their response from 'Not at all stressed' to 'Very stressed' on a 100-points sliding bar.
|
8 weeks
|
Alertness
Time Frame: 8 weeks
|
Participants will complete a daily set of cognitive games, delivered through a mobile phone-based application.
The outcome measure from the games is a 3-min psychomotor vigilance task measuring sustained attention.
Specifically, the investigators examine median reaction time and lapses (reaction time > 500ms).
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUHSsleepstudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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