Monitoring Sleep, Wellbeing, and Glucose Metabolism in PGY1s

Sleep Clinical Trial

Official title:

Monitoring Sleep, Wellbeing, and Glucose Metabolism in Postgraduate Year 1 Doctors on Traditional and Float Call Shifts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695235
• Other study ID #: NUHSsleepstudy
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: National University, Singapore
• Contact: Stijn Agus Adrianus Massar, PhD
• Phone: +65 66015238
• Email: mdcsaam[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases
• Sleep

Intervention

Device:
• CGM
Wearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.
• Oura ring
Wearable sleep tracking device

Behavioral:
• Cognitive tasks and questionnaires
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.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore	(No States Listed)

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	Sleep duration and timing will be measured	8 weeks
Primary	Wellbeing	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
Primary	Glucose monitoring	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
Primary	Alertness	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