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Operational Trial of Dayzz App

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ClinicalTrials.gov Identifier: NCT04224285
Recruitment Status : Active, not recruiting
First Posted : January 13, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Laura K. Barger, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Other: Dayzz app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: wait list control
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Operational Trial of Dayzz App
Actual Study Start Date : August 12, 2020
Actual Primary Completion Date : May 27, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: 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.
Other: Dayzz app
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution

No Intervention: 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.



Primary Outcome Measures :
  1. Primary Aim 1: Sleep Behavior 1 [ Time Frame: Up to 9 months ]
    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.

  2. Primary Aim 1: Sleep Behavior 2 [ Time Frame: 1 week of daily eDiary in both Month 1 and Month 3 ]
    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).

  3. Primary Aim 1: Sleep Behavior 3 [ Time Frame: Up to 9 months ]
    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.

  4. Primary Aim 2: Sleep Duration [ Time Frame: 1 week of daily eDiary in both Month 1 and Month 3 ]
    Sleep duration will be reported in the eDiary.

  5. Primary Aim 2: Sleep Quality [ Time Frame: Up to 9 months ]
    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).


Secondary Outcome Measures :
  1. Secondary Aim 1: Absenteeism [ Time Frame: Up to 9 months ]
    Unscheduled absences and disability day usage will be collected by self-report on the monthly questionnaires.

  2. Secondary Aim 1: Performance/Productivity - Absenteeism [ Time Frame: Up to 9 months ]
    World Health Organization Health Work Performance Questionnaire Short Form (HPQ) will be used to assess performance/productivity via 4-week absolute absenteeism. Absenteeism is scored in terms of hours lost per month, which is to say that a high score indicates a higher amount of absenteeism. The measure of absolute absenteeism is expressed in raw hours, with a negative lower bound (if the person works more than expected) and an upper bound equal to the number of hours the respondent is expected to work.

  3. Secondary Aim 1: Performance/Productivity - Presenteeism [ Time Frame: Up to 9 months ]
    World Health Organization Health Work Performance Questionnaire Short Form (HPQ) will be used to assess performance/productivity via absolute presenteeism. Presenteeism has a lower bound of 0 (total lack of performance during time on the job) and an upper bound of 100 (no lack of performance during time on the job). A higher score indicates a lower amount of lost performance.

  4. Secondary Aim 2: Mood - Monthly questionnaire [ Time Frame: Up to 9 months ]
    Mood will be self-reported via a 7-point Likert scale anchored at 0 with "Very poor" and 7 with "Very good." Higher numbers indicate better outcome.

  5. Secondary Aim 2: Mood - eDiary [ Time Frame: 1 week of daily eDiary in both Month 1 and Month 3 ]
    Mood will be self-reported via 100 mm visual analog scales anchored with "Sad" at 0 and "Happy" at 100. Higher scores indicate a better outcome.

  6. Secondary Aim 2: Alertness - Monthly questionnaire [ Time Frame: Up to 9 months ]
    Alertness will be self-reported via a 7-point Likert scale anchored at 0 with "Very poor" and 7 with "Very good." Higher numbers indicate better outcome.

  7. Secondary Aim 2: Alertness - eDiary [ Time Frame: 1 week of daily eDiary in both Month 1 and Month 3 ]
    Alertness will be self-reported via 100 mm visual analog scales anchored with "Sleepy" at 0 and "Alert" at 100. Higher scores indicate a better outcome.

  8. Secondary Aim 2: Energy - Monthly questionnaire [ Time Frame: Up to 9 months ]
    Energy will be self-reported via a 7-point Likert scale anchored at 0 with "Very low" and 7 with "Very high." Higher numbers indicate better outcome.

  9. Secondary Aim 2: Energy - eDiary [ Time Frame: 1 week of daily eDiary in both Month 1 and Month 3 ]
    Energy will be self-reported via 100 mm visual analog scales anchored with "Sluggish" at 0 and "Energetic" at 100. Higher scores indicate a better outcome.

  10. Secondary Aim 3: Adverse Health and Safety Outcomes - Motor Vehicle Crashes [ Time Frame: Up to 9 months ]
    Motor vehicle crashes will be self-reported on the monthly questionnaires (count per month).

  11. Secondary Aim 3: Adverse Health and Safety Outcomes - Near Crash Incidents [ Time Frame: Up to 9 months ]
    Near crash incidents will be self-reported on the monthly questionnaires (count per month).

  12. Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries [ Time Frame: Up to 9 months ]
    Injuries will be self-reported on the monthly questionnaires (count per month).

  13. Secondary Aim 3: Adverse Health and Safety Outcomes - Attentional Failures [ Time Frame: Up to 9 months ]
    Attentional failures (nodding off) will be self-reported on the monthly questionnaires (count per month).

  14. Secondary Aim 4: Health Care Costs [ Time Frame: Up to 9 months ]
    Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224285


Locations
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United States, Massachusetts
Partners Healthcare
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Study Director: Rebecca Robbins, PhD Brigham and Women's Hospital / Harvard Medical School
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Responsible Party: Laura K. Barger, Associate Physiologist - BWH / Assistant Professor - HMS, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04224285    
Other Study ID Numbers: 2019P003277
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura K. Barger, Brigham and Women's Hospital:
sleep
sleep deficiency
workplace health
occupational health
workplace health promotion
mobile health
mHealth
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders