SleephiSG-SHSNCT04878380
hiSG Sleep Health Study
A study testing Fitbit, Sleep education tips and Goal-setting in people with Sleep, run by National University of Singapore at 1 site in Singapore.
Trial summary
The hiSG Sleep Health Study seeks to investigate the efficacy of education + goal-based programmes for the promotion of healthy sleep habits and to evaluate its impact on daytime sleepiness and mental health. Read more about this study
- Who is it for?
- Ages 21 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Fitbit, Sleep education tips and Goal-setting
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Aug 2021to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Existing participants in the hiSG study
- Aged 21-42y
- Sleep <7h habitually on weekdays
Who cannot join
- Shift workers
- Those required to work in different time zones
- Currently Pregnant
- Nursing mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Goal-Based Interventions to Promote and Sustain Healthy Sleep Habits
The hiSG Sleep Health Study seeks to investigate the efficacy of education + goal-based programmes for the promotion of healthy sleep habits and to evaluate its impact on daytime sleepiness and mental health.
Read the detailed description
This study is a sub-study under the existing Health Insights Singapore study (hiSG). The hiSG study is a longitudinal cohort study among working adults (aged 21-42y), monitoring health parameters through a Fitbit tracker and mobile phone-based questionnaires.
The hiSG Sleep Health Study (hiSG SHS) sub-study, will evaluate the efficacy of two goal-based interventions for improving sleep. Participants will be recruited from the existing hiSG subject pool (target N=300), and should have a habitual sleep duration below the recommended 7h (as determined from the currently available hiSG data). Following informed consent, participants will be randomized by the study team into two groups, a) Goal-Setting and b) Tracking, based on a 2:1 ratio, i.e. in the event 300 participants are enrolled, 200 will be allocated to Goal-Setting and 100 to Tracking.
The study is 22 weeks long and will proceed in 3 main phases, namely, 1) Baseline (Week 1-2) 2) Intervention (Week 3-12), and 3) Follow-up (Week 13-22).
Throughout the study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week.
Daily questionnaires probing daytime sleepiness, mood, and stress levels as well as once-per-study phase sleep health, sleep hygiene, work-related stress and mental wellbeing questionnaires will be pushed to participants during the baseline (Week 1-2), intervention (Week 11-12) and follow-up periods (Week 21-22) via the hiSG mobile application. Participants will also be reimbursed for completion of these questionnaires.
Both groups will also receive sleep education tips before the intervention period. During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight.
In addition, given the pervasive telecommuting arrangements presently enforced in many workplaces to curb spread of the COVID-19 pandemic, a work-life balance, burnout and work engagement questionnaire will be administered to better understand reasons that could contribute to poor sleep health and mental wellbeing.
- Conditions
- Sleep
- Being tested
- Fitbit, Sleep education tips, Goal-setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
A consumer sleep tracker will be used to monitor sleep patterns throughout the study
Sleep education tipsBehavioural
Sleep tips will be provided before the intervention phase
Goal-settingBehavioural
During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight.
| Study group | Role | What they receive |
|---|---|---|
| Tracking | Active comparator | Throughout the 22 week study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week. Receives: Device: Fitbit; Behavioral: Sleep education tips |
| Goal-Setting | Experimental | Throughout the 22 week study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week.
During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight. Receives: Device: Fitbit; Behavioral: Sleep education tips; Behavioral: Goal-setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep duration measured by wearable device (mins)
We hypothesize that the Goal-Setting group will exhibit longer sleep duration across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in sleep duration regularity (standard deviation) measured by wearable device (mins)
We hypothesize that the Goal-Setting group will exhibit more consistent sleep durations across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in bedtimes measured by wearable device
We hypothesize that the Goal-Setting group will exhibit earlier bedtimes across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in bedtime regularity (standard deviation) measured by wearable device
We hypothesize that the Goal-Setting group will exhibit more consistent bedtimes across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in social jetlag (midpoint of sleep on weekends - weekdays) measured by wearable device
We hypothesize that the Goal-Setting group will exhibit reduced social jetlag measures across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in scores on the Sleep Health Index questionnaire
We hypothesize that the Goal-Setting group will exhibit improved sleep health across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in scores on the Sleep Hygiene Scale questionnaire
We hypothesize that the Goal-Setting group will exhibit better sleep hygiene across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in scores on the Work-Related Perseverative Thought and Work Home Interference questionnaires
We hypothesize that the Goal-Setting group will exhibit reduced work stress levels across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Change in scores on the Oldenberg Burnout Inventory questionnaire
We hypothesize that the Goal-Setting group will exhibit reduced burnout across both Intervention and Follow-Up phases, compared to the Tracking group.
Measured: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Secondary outcomes (5)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime sleepiness levels.
We hypothesize that longer sleep duration will be associated with improved next day sleepiness [0-100 scale]
Measured: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood and stress levels.
We hypothesize that longer sleep duration will be associated with improved next day stress levels [0-100 scale]
Measured: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime motivational levels.
We hypothesize that longer sleep duration will be associated with improved next day motivational levels [0-100 scale]
Measured: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood levels.
We hypothesize that longer sleep duration will be associated with improved next day mood levels [0-100 scale]
Measured: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Associations between Oldenberg Burnout Inventory, Work-Related Perseverative Thought and Work Home Interference with poorer Sleep Health Index scores.
We also hypothesize that individuals who score poorly on these burnout scales will also exhibit poorer sleep health scores.
Measured: Average scores (Week 1-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start15 Aug 2021
- Primary completion16 Jan 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Health Promotion Board, Singapore
- Responsible party
- Principal investigator, Michael W.L. Chee, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878380
- Sponsor's protocol ID
- hiSG-SHS
- Acronym
- hiSG-SHS
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ong JL, Massar SAA, Lau T, Ng BKL, Chan LF, Koek D, Cheong K, Chee MWL. A randomized-controlled trial of a digital, small incentive-based intervention for working adults with short sleep. Sleep. 2023 May 10;46(5):zsac315. doi: 10.1093/sleep/zsac315.
PubMed 36546351
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Goal-Based Interventions to Promote and Sustain Healthy Sleep Habits
- ClinicalTrials.gov ID
- NCT04878380
- Acronym / sponsor ID
- hiSG-SHS / hiSG-SHS
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Health Promotion Board, Singapore
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hiSG Sleep Health Study seeks to investigate the efficacy of education + goal-based programmes for the promotion of healthy sleep habits and to evaluate its impact on daytime sleepiness and mental health.
Detailed description
This study is a sub-study under the existing Health Insights Singapore study (hiSG). The hiSG study is a longitudinal cohort study among working adults (aged 21-42y), monitoring health parameters through a Fitbit tracker and mobile phone-based questionnaires.
The hiSG Sleep Health Study (hiSG SHS) sub-study, will evaluate the efficacy of two goal-based interventions for improving sleep. Participants will be recruited from the existing hiSG subject pool (target N=300), and should have a habitual sleep duration below the recommended 7h (as determined from the currently available hiSG data). Following informed consent, participants will be randomized by the study team into two groups, a) Goal-Setting and b) Tracking, based on a 2:1 ratio, i.e. in the event 300 participants are enrolled, 200 will be allocated to Goal-Setting and 100 to Tracking.
The study is 22 weeks long and will proceed in 3 main phases, namely, 1) Baseline (Week 1-2) 2) Intervention (Week 3-12), and 3) Follow-up (Week 13-22).
Throughout the study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week.
Daily questionnaires probing daytime sleepiness, mood, and stress levels as well as once-per-study phase sleep health, sleep hygiene, work-related stress and mental wellbeing questionnaires will be pushed to participants during the baseline (Week 1-2), intervention (Week 11-12) and follow-up periods (Week 21-22) via the hiSG mobile application. Participants will also be reimbursed for completion of these questionnaires.
Both groups will also receive sleep education tips before the intervention period. During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight.
In addition, given the pervasive telecommuting arrangements presently enforced in many workplaces to curb spread of the COVID-19 pandemic, a work-life balance, burnout and work engagement questionnaire will be administered to better understand reasons that could contribute to poor sleep health and mental wellbeing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracking | Active comparator | Device: Fitbit, Behavioral: Sleep education tipsThroughout the 22 week study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week. |
| Goal-Setting | Experimental | Device: Fitbit, Behavioral: Sleep education tips, Behavioral: Goal-settingThroughout the 22 week study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week. During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight. |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Existing participants in the hiSG study
- Aged 21-42y
- Sleep <7h habitually on weekdays
Key exclusion criteria (4 listed)
- Shift workers
- Those required to work in different time zones
- Currently Pregnant
- Nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitA consumer sleep tracker will be used to monitor sleep patterns throughout the study | Device | Goal-Setting, Tracking |
| Sleep education tipsSleep tips will be provided before the intervention phase | Behavioural | Goal-Setting, Tracking |
| Goal-settingDuring the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight. | Behavioural | Goal-Setting |
Primary outcome
Change in sleep duration measured by wearable device (mins)
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit longer sleep duration across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in sleep duration regularity (standard deviation) measured by wearable device (mins)
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit more consistent sleep durations across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in bedtimes measured by wearable device
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit earlier bedtimes across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in bedtime regularity (standard deviation) measured by wearable device
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit more consistent bedtimes across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in social jetlag (midpoint of sleep on weekends - weekdays) measured by wearable device
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit reduced social jetlag measures across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in scores on the Sleep Health Index questionnaire
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit improved sleep health across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in scores on the Sleep Hygiene Scale questionnaire
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit better sleep hygiene across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in scores on the Work-Related Perseverative Thought and Work Home Interference questionnaires
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit reduced work stress levels across both Intervention and Follow-Up phases, compared to the Tracking group.
Change in scores on the Oldenberg Burnout Inventory questionnaire
Time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
We hypothesize that the Goal-Setting group will exhibit reduced burnout across both Intervention and Follow-Up phases, compared to the Tracking group.
5 secondary outcomes
Bi-directional relationships between amount of nocturnal sleep obtained and daytime sleepiness levels.
Time frame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood and stress levels.
Time frame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime motivational levels.
Time frame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood levels.
Time frame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
Associations between Oldenberg Burnout Inventory, Work-Related Perseverative Thought and Work Home Interference with poorer Sleep Health Index scores.
Time frame: Average scores (Week 1-2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 36546351Ong JL, Massar SAA, Lau T, Ng BKL, Chan LF, Koek D, Cheong K, Chee MWL. A randomized-controlled trial of a digital, small incentive-based intervention for working adults with short sleep. Sleep. 2023 May 10;46(5):zsac315. doi: 10.1093/sleep/zsac315.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit, Sleep education tips and Goal-setting in people with Sleep, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep duration measured by wearable device (mins) (time frame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.