Clinical trial NCT04878380: hiSG Sleep Health Study
Official title: Evaluation of Goal-Based Interventions to Promote and Sustain Healthy Sleep Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Health Promotion Board, Singapore
First posted: 2021-05-07
Enrollment: 225
Sex: ALL
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Existing participants in the hiSG study
* Aged 21-42y
* Sleep \<7h habitually on weekdays

Exclusion Criteria:

* Shift workers
* Those required to work in different time zones
* Currently Pregnant
* Nursing mothers

Primary outcomes:
measure: Change in sleep duration measured by wearable device (mins)
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in sleep duration regularity (standard deviation) measured by wearable device (mins)
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in bedtimes measured by wearable device
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in bedtime regularity (standard deviation) measured by wearable device
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in social jetlag (midpoint of sleep on weekends - weekdays) measured by wearable device
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in scores on the Sleep Health Index questionnaire
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in scores on the Sleep Hygiene Scale questionnaire
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in scores on the Work-Related Perseverative Thought and Work Home Interference questionnaires
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
measure: Change in scores on the Oldenberg Burnout Inventory questionnaire
timeFrame: Baseline (Week 1-2), Intervention (Week 11-12), Follow up (Week 21-22)
Secondary outcomes:
measure: Bi-directional relationships between amount of nocturnal sleep obtained and daytime sleepiness levels.
timeFrame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
measure: Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood and stress levels.
timeFrame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
measure: Bi-directional relationships between amount of nocturnal sleep obtained and daytime motivational levels.
timeFrame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
measure: Bi-directional relationships between amount of nocturnal sleep obtained and daytime mood levels.
timeFrame: Day-by-day associations (Week 1-2, Week 11-12, Week 21-22)
measure: Associations between Oldenberg Burnout Inventory, Work-Related Perseverative Thought and Work Home Interference with poorer Sleep Health Index scores.
timeFrame: Average scores (Week 1-2)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Centre for Sleep and Cognition
Study officials:
References: