Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-28 @ 6:37 AM
Study NCT ID:
NCT05695235
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2022-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Sleep, Wellbeing, and Glucose Metabolism in PGY1s
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-22', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep', 'timeFrame': '8 weeks', 'description': 'Sleep duration and timing will be measured'}, {'measure': 'Wellbeing', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Glucose monitoring', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Alertness', 'timeFrame': '8 weeks', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nWearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NUHS Postgraduate year 1 doctors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NUHS Postgraduate year 1 doctors\n* Above 21 years of age\n* Completing their year 1 rotations in 2021 or 2022\n\nExclusion Criteria:\n\n* As this is an observational study with minimal risk, in an restricted pool of participants, no further exclusion criteria will be applied for participation.'}, 'identificationModule': {'nctId': 'NCT05695235', 'briefTitle': 'Monitoring Sleep, Wellbeing, and Glucose Metabolism in PGY1s', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Monitoring Sleep, Wellbeing, and Glucose Metabolism in Postgraduate Year 1 Doctors on Traditional and Float Call Shifts', 'orgStudyIdInfo': {'id': 'NUHSsleepstudy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traditional call', 'description': '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)', 'interventionNames': ['Device: CGM', 'Device: Oura ring', 'Behavioral: Cognitive tasks and questionnaires']}, {'label': 'Float call', 'description': 'In the night float system, residents work from 8 pm to 8 am for 5 - 7 consecutive nights once every month', 'interventionNames': ['Device: CGM', 'Device: Oura ring', 'Behavioral: Cognitive tasks and questionnaires']}], 'interventions': [{'name': 'CGM', 'type': 'DEVICE', 'description': 'Wearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.', 'armGroupLabels': ['Float call', 'Traditional call']}, {'name': 'Oura ring', 'type': 'DEVICE', 'description': 'Wearable sleep tracking device', 'armGroupLabels': ['Float call', 'Traditional call']}, {'name': 'Cognitive tasks and questionnaires', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Float call', 'Traditional call']}]}, 'contactsLocationsModule': {'locations': [{'zip': '117597', 'city': 'Singapore', 'state': '(No States Listed)', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Michael WL Chee, MBBS', 'role': 'CONTACT', 'email': 'michael.chee@nus.edu.sg', 'phone': '+65 65164916'}, {'name': 'Alyssa Ng', 'role': 'CONTACT', 'email': 'alyssa.ng@u.nus.edu', 'phone': '+6584044909'}], 'facility': 'National University of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Stijn Agus Adrianus Massar, PhD', 'role': 'CONTACT', 'email': 'mdcsaam@nus.edu.sg', 'phone': '+65 66015238'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael W.L. Chee', 'investigatorAffiliation': 'National University of Singapore'}}}}