- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05977517
Sleep, Learning and Wellbeing in NUS Undergraduates: The NUS1000 Study (NUS1000)
July 26, 2023 updated by: Michael W.L. Chee, National University of Singapore
NUS1000 is a large scale freshman-year study of undergraduate sleep, well-being and learning patterns that has unique key features: (1) continuous objective multi-dimensional data gathered with passive sensing of sleep and stress over a semester, (2) utilisation of Learning Management System-based outcome data as a marker of study behaviour and academic achievement.
The goal is to gather information that can be used to improve student sleep, mental wellbeing and performance.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The first year in university can be a challenging experience for undergraduates who must learn to cope with learning in an unfamiliar environment, form new relationships, live away from home and/or might have to manage personal finances for the first time.
These academic, social, and personal demands can result in significant stress, affecting sleep, learning and mental/emotional wellbeing.
Characterizing and understanding the time-course and inter-relationship of these demands and their consequences is crucial for making science-based improvements to a student's university experience.
To this end, the investigators will longitudinally evaluate sleep, learning and wellbeing in ~1000 first-year students as they adapt to university life to understand how these behaviours fluctuate and interact throughout the academic term.
Study Type
Observational
Enrollment (Estimated)
500
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
NUS Freshmen students
Description
Inclusion Criteria:
- NUS first-year students with smartphones operating on Android 8.0 and up, or iOS 14.0 or later
Exclusion Criteria:
Participants will be required to :
- Have their sleep and physical activity rhythms will be recorded via wearable sensors, while they continue daily life as usual.
- Complete periodic questionnaires, short daily surveys and daily audio diaries on their smartphones.
- Agree to interactions with their smartphones and as well as grades tracked. Participants who do not agree to have these measures recorded will not be eligible for the study.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sleep duration and timing from the start to the end of the semester
Time Frame: 20 weeks
|
The Oura ring is a sleep-tracking device worn on the finger.
During the study, participants will need to sync their devices to a mobile app.
|
20 weeks
|
|
Change from baseline sleep habits from the start to the end of the semester
Time Frame: Week 1-2, Week 8-9, and Week 17-18
|
Participants will also be required to complete a set of sleep questionnaires probing sleep habits (bedtime, wake time, time taken to fall asleep, etc.)
|
Week 1-2, Week 8-9, and Week 17-18
|
|
Change in daily well-being from the start to the end of the semester
Time Frame: 20 weeks
|
Participants will be prompted to fill in brief questions on daily well-being.
At the end of each assessment, participants will be required to record an audio clip of their day, without any personal identifiers, for mood/sentiment analysis.
|
20 weeks
|
|
Change from baseline well being from the start to the end of the semester
Time Frame: Week 1-2, Week 8-9, and Week 17-18
|
Participants will also be required to complete a set of well-being questionnaires (e.g., feelings of connectedness or isolation, levels of stress, etc.)
|
Week 1-2, Week 8-9, and Week 17-18
|
|
Change in learning outcomes from the start to the end of the semester
Time Frame: 20 weeks
|
Grades from quiz/assignments for each module will be collected.
|
20 weeks
|
|
Change in learning patterns from the start to the end of the semester
Time Frame: 20 weeks
|
Student interactions with the LMS-system will be collected, such as the number of page/file views.
|
20 weeks
|
|
Change in mood from the start to the end of the semester
Time Frame: 20 weeks
|
At the end of each day, participants will be required to record an audio clip of their day, without any personal identifiers, for mood analysis.
|
20 weeks
|
|
Change in time-use patterns from the start to the end of the semester
Time Frame: Week 1-2, Week 8-9, and Week 17-18
|
Participants will be asked to fill out a time-use diary over three 2-week periods throughout the semester, indicating the activities they engaged in over the past day
|
Week 1-2, Week 8-9, and Week 17-18
|
|
Change in smartphone touchscreen interaction patterns from the start to the end of the semester
Time Frame: 20 weeks
|
Phone taps will be tracked automatically through an EU-GDPR (the European Union's stringent privacy regulation) compliant smartphone app (QuantActions).
This application logs human-smartphone screen interactions during regular use by logging a location-specific timestamp for each screen contact.
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in movement patterns from the start to the end of the semester
Time Frame: 20 weeks
|
The investigator's in-house smartphone app (Z4IP) will extract movement patterns from location data that will only be kept on the participant's phone up to 96 hours for these computations.
The extracted movement patterns (and not geographical locations) will then be uploaded to secure servers, tagged to subject IDs without any personal identifiers, i.e., names and emails will not be linked to their movement patterns.
As this component is optional, participants will be asked to indicate if they would like to opt-in at the informed consent stage.
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
July 30, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
June 27, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Actual)
August 4, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- NUS1000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
-
Hospital Felicio RochoNot yet recruitingSleep Apnea/Hypopnea Syndrome | Sleep Apnea Syndrome, Obstructive | Sleep Apnea Syndrome (OSAS) | Sleep Apnea - Obstructive
Clinical Trials on Sleep and well-being tracking
-
Columbia UniversityCompletedPoor Quality SleepUnited States
-
University Hospital, CaenRecruiting
-
University of Wisconsin, MadisonNot yet recruiting
-
University of New MexicoNational Institute of Mental Health (NIMH)Active, not recruitingStress, Emotional | Mental Health Disorder | Mental Health Issue | Economic ProblemsUnited States
-
Universidad Internacional de ValenciaUniversity of Guadalajara; Universidad Autonoma de Ciudad Juarez; Universidad... and other collaboratorsRecruitingDepression | Wellbeing | Stress | AnxietyBrazil, Ecuador, Mexico, Netherlands, Peru, Spain
-
IRCCS San Raffaele RomaCompletedCoping Behavior | Distress, EmotionalItaly
-
University of Wisconsin, MadisonNot yet recruiting
-
Islamic Azad University, Isfahan (Khorasgan) BranchCompletedUlcerative ColitisIran, Islamic Republic of
-
Hospital Italiano de Buenos AiresUnknownDepression | Anxiety | Cognition Disorders | Shift-Work Sleep Disorder
-
Fatima Jinnah Women UniversityRecruitingWell-being, Emotional and Behavioral Problems, AdolescentsPakistan