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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 :

  1. Have their sleep and physical activity rhythms will be recorded via wearable sensors, while they continue daily life as usual.
  2. Complete periodic questionnaires, short daily surveys and daily audio diaries on their smartphones.
  3. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Singapore

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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