Operational Trial of Dayzz App

NCT ID: NCT04224285

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2021-09-30

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.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Early Dayzz

Participants receive a Sleep Health and Wellness education session and download the Dayzz app. Complete monthly questionnaires for up to 9 months and 2 weeks of sleep diaries.

Group Type: EXPERIMENTAL

Dayzz app

Intervention Type: OTHER

Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution

Late Dayzz

Complete monthly questionnaires for up to 9 months and 2 weeks of sleep diaries. At the end of nine months, participants have the opportunity to receive a Sleep Health and Wellness education session.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dayzz app

Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laura K. Barger

Associate Physiologist - BWH / Assistant Professor - HMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Robbins, PhD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital / Harvard Medical School

Locations

Partners Healthcare

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36104122 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34986183 (View on PubMed)

Other Identifiers

2019P003277

Identifier Type: -

Identifier Source: org_study_id