NCT04878380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

April 27, 2021

Last Update Submit

January 13, 2023

Conditions

Sleep

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Average scores (Week 1-2)

Study Arms (2)

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.

Device: FitbitBehavioral: 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.

Device: FitbitBehavioral: Sleep education tipsBehavioral: Goal-setting

Interventions

FitbitDEVICE

A consumer sleep tracker will be used to monitor sleep patterns throughout the study

Goal-SettingTracking
Sleep education tipsBEHAVIORAL

Sleep tips will be provided before the intervention phase

Goal-SettingTracking
Goal-settingBEHAVIORAL

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.

Goal-Setting

Eligibility Criteria

Age21 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Sleep and Cognition

Singapore, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 36546351DERIVED

MeSH Terms

Interventions

Organizational Objectives

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 7, 2021

Study Start

August 15, 2021

Primary Completion

January 16, 2022

Study Completion

August 16, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

SG(1)