Clinical trial NCT04224285: Operational Trial of Dayzz App
Official title: Operational Trial of Dayzz App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: sleep
sleep deficiency
workplace health
occupational health
workplace health promotion
mobile health
mHealth
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 1355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wait list control
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Sleep deficiency is a hidden cost of our 24-7 society, with 70% of Americans admitting that they routinely obtain insufficient sleep, 30% of US workers report sleeping less than 6 hours per night, and it is estimated that 50-70 million individuals have a sleep disorder. Undiagnosed and untreated sleep disorders are associated with poor health outcomes for the individual and generate substantial costs for the employer. Diminished alertness resulting from sleep deficiency or undiagnosed and untreated sleep disorders contributes to absenteeism, presenteeism (diminished work performance at work), health care expenditure, occupational injuries, workplace accidents, and commute-related motor vehicle crashes; all of which result in substantial direct and indirect costs. The investigators have shown that adverse impacts on employees and employers can be mitigated through a sleep health education and sleep disorder screening program which have been implemented in a variety of industries. Further, smartphone apps are becoming popular. Dayzz has created a personalized sleep training app that evaluates sleep issues and offers a holistic sleep improvement solution. It is unique in that the sleep app uses evidence-based, big-data-based algorithms to provide personalized sleep training plans. The sleep solutions are tailored to the individual user and leverages unique motivational strategies and continuous supportive messaging. The investigators hypothesize that the Dayzz app, offering a personalized, scientifically based sleep training plan, might further promote improved health, safety and well-being. This clinical trial will implement the sleep health education and sleep disorders screening program in combination with the Dayzz app.

Detailed description: Specifically, the investigators will test the hypotheses that:

Primary Aim 1: Early Dayzz participants who use the app will report positive changes in sleep behavior as compared to the Late Dayzz participants.

Primary Aim 2: Early Dayzz participants who use the app will have increased sleep duration and sleep quality as compared to the Late Dayzz participants.

Secondary Aim 1: Early Dayzz participants who use the app will have fewer unscheduled absences and higher performance/productivity as compared to the Late Dayzz participants.

Secondary Aim 2: Early Dayzz participants who use the app will have improved mood and alertness and increased energy as compared to the Late Dayzz participants.

Secondary Aim 3: Early Dayzz participants who use the app will report fewer adverse health and safety outcomes as compared to the Late Dayzz participants.

Secondary Aim 4: Early Dayzz participants who use the app will have lower health care costs over a 9-month follow-up period as compared to the Late Dayzz participants.

Eligibility criteria: Inclusion Criteria:

* Employee of Harvard University or Harvard-affiliated institution or hospital.
* Nominally work a day schedule.
* Own and use a smart phone.
* Regularly use a smart phone app (i.e., once per week).

Exclusion Criteria:

* Regularly work evening, night or rotating shifts.
* Pregnant or breast-feeding.

Primary outcomes:
measure: Primary Aim 1: Sleep Behavior 1
timeFrame: Up to 9 months
measure: Primary Aim 1: Sleep Behavior 2
timeFrame: 1 week of daily eDiary in both Month 1 and Month 3
measure: Primary Aim 1: Sleep Behavior 3
timeFrame: Up to 9 months
measure: Primary Aim 2: Sleep Duration
timeFrame: 1 week of daily eDiary in both Month 1 and Month 3
measure: Primary Aim 2: Sleep Quality
timeFrame: Up to 9 months
Secondary outcomes:
measure: Secondary Aim 1: Absenteeism
timeFrame: Up to 9 months
measure: Secondary Aim 1: Performance/Productivity - Absenteeism
timeFrame: Up to 9 months
measure: Secondary Aim 1: Performance/Productivity - Presenteeism
timeFrame: Up to 9 months
measure: Secondary Aim 2: Mood - Monthly questionnaire
timeFrame: Up to 9 months
measure: Secondary Aim 2: Mood - eDiary
timeFrame: 1 week of daily eDiary in both Month 1 and Month 3
measure: Secondary Aim 2: Alertness - Monthly questionnaire
timeFrame: Up to 9 months
measure: Secondary Aim 2: Alertness - eDiary
timeFrame: 1 week of daily eDiary in both Month 1 and Month 3
measure: Secondary Aim 2: Energy - Monthly questionnaire
timeFrame: Up to 9 months
measure: Secondary Aim 2: Energy - eDiary
timeFrame: 1 week of daily eDiary in both Month 1 and Month 3
measure: Secondary Aim 3: Adverse Health and Safety Outcomes - Motor Vehicle Crashes
timeFrame: Up to 9 months
measure: Secondary Aim 3: Adverse Health and Safety Outcomes - Near Crash Incidents
timeFrame: Up to 9 months
measure: Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries
timeFrame: Up to 9 months
measure: Secondary Aim 3: Adverse Health and Safety Outcomes - Attentional Failures
timeFrame: Up to 9 months
measure: Secondary Aim 4: Health Care Costs
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners Healthcare
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital / Harvard Medical School
name: Rebecca Robbins, PhD
role: STUDY_DIRECTOR
References:
citation: Robbins R, Weaver MD, Quan SF, Sullivan JP, Qadri S, Glasner L, Cohen-Zion M, Czeisler CA, Barger LK. Evaluating the impact of a sleep health education and a personalised smartphone application on sleep, productivity and healthcare utilisation among employees: results of a randomised clinical trial. BMJ Open. 2022 Sep 14;12(9):e062121. doi: 10.1136/bmjopen-2022-062121.
citation: Robbins R, Weaver MD, Quan SF, Sullivan JP, Cohen-Zion M, Glasner L, Qadri S, Czeisler CA, Barger LK. A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. PLoS One. 2022 Jan 5;17(1):e0260828. doi: 10.1371/journal.pone.0260828. eCollection 2022.