Operational Trial of Dayzz App

NCT04224285 | Completed

• 1 other identifier: 2019P003277
• Study Type: interventional
• Target: 1,355
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

sleep; sleep deficiency; workplace health; occupational health; workplace health promotion; mobile health; mHealth

Outcome Measures

Primary Outcomes (5)

• Primary Aim 1: Sleep Behavior 1

  Sleep behaviors (e.g., sleep on a consistent schedule, sleep in later) will be self-reported on the end-of-study survey. 100 mm visual analog scales anchored with "Not at all" at 0 and "All the time" at 100 will be used. Higher scores indicate a better outcome.

  Up to 9 months

• Primary Aim 1: Sleep Behavior 2

  Sleep behaviors will also be tracked on the eDiary (e.g., consistent sleep schedule, as calculated with the regularity index). The Sleep Regularity Index calculates the percentage probability of an individual being in the same state (asleep vs. awake) at any two time-points 24 h apart, averaged across the study. The index is scaled so that an individual who sleeps and wakes at exactly the same times each day scores 100 (better outcome), whereas an individual who sleeps and wakes at random scores 0 (worse outcome).

  1 week of daily eDiary in both Month 1 and Month 3

• Primary Aim 1: Sleep Behavior 3

  Outcomes in sleep behaviors will be further detailed by self-report by completing a checklist of potential positive changes. Participants will select the healthy sleep changes they have made while completing the protocol, "During this study, have you changed any sleep-related behaviors to improve your sleep since participating in the study (check all that apply)?" Higher numbers of positive changes selected indicate a better outcome.

  Up to 9 months

• Primary Aim 2: Sleep Duration

  Sleep duration will be reported in the eDiary.

  1 week of daily eDiary in both Month 1 and Month 3

• Primary Aim 2: Sleep Quality

  Sleep quality will be measured with the Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The participant self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper. Minimum Score = 0 (better outcome); Maximum Score = 21 (worse outcome).

  Up to 9 months

Secondary Outcomes (14)

• Secondary Aim 1: Absenteeism

  Up to 9 months

• Secondary Aim 1: Performance/Productivity - Absenteeism

  Up to 9 months

• Secondary Aim 1: Performance/Productivity - Presenteeism

  Up to 9 months

• Secondary Aim 2: Mood - Monthly questionnaire

  Up to 9 months

• Secondary Aim 2: Mood - eDiary

  1 week of daily eDiary in both Month 1 and Month 3

Study Arms (2)

Early Dayzz

EXPERIMENTAL

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.

Other: Dayzz app

Late Dayzz

NO INTERVENTION

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.

Interventions

Dayzz app OTHER

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

Early Dayzz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Partners Healthcare

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 36104122 DERIVED

• 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.

  PMID: 34986183 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Rebecca Robbins, PhD

  Brigham and Women's Hospital / Harvard Medical School

  STUDY DIRECTOR

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: Associate Physiologist - BWH / Assistant Professor - HMS

Model Details: wait list control

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 13, 2020
• Study Start: August 12, 2020
• Primary Completion: May 27, 2021
• Study Completion: September 30, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data will become available two years following the primary publication. It will be available for 5 years.
• Access Criteria: Consistent with MGB IRB policies and procedures.

Locations

US (1)