Operational Trial of Dayzz App

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Operational Trial of Dayzz App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224285
• Other study ID #: 2019P003277
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: June 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1355
• Est. completion date: September 30, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Dayzz app
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution

Locations

Country	Name	City	State
United States	Partners Healthcare	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	Secondary Aim 1: Absenteeism	Unscheduled absences and disability day usage will be collected by self-report on the monthly questionnaires.	Up to 9 months
Secondary	Secondary Aim 1: Performance/Productivity - Absenteeism	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.	Up to 9 months
Secondary	Secondary Aim 1: Performance/Productivity - Presenteeism	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.	Up to 9 months
Secondary	Secondary Aim 2: Mood - Monthly questionnaire	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.	Up to 9 months
Secondary	Secondary Aim 2: Mood - eDiary	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.	1 week of daily eDiary in both Month 1 and Month 3
Secondary	Secondary Aim 2: Alertness - Monthly questionnaire	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.	Up to 9 months
Secondary	Secondary Aim 2: Alertness - eDiary	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.	1 week of daily eDiary in both Month 1 and Month 3
Secondary	Secondary Aim 2: Energy - Monthly questionnaire	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.	Up to 9 months
Secondary	Secondary Aim 2: Energy - eDiary	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.	1 week of daily eDiary in both Month 1 and Month 3
Secondary	Secondary Aim 3: Adverse Health and Safety Outcomes - Motor Vehicle Crashes	Motor vehicle crashes will be self-reported on the monthly questionnaires (count per month).	Up to 9 months
Secondary	Secondary Aim 3: Adverse Health and Safety Outcomes - Near Crash Incidents	Near crash incidents will be self-reported on the monthly questionnaires (count per month).	Up to 9 months
Secondary	Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries	Injuries will be self-reported on the monthly questionnaires (count per month).	Up to 9 months
Secondary	Secondary Aim 3: Adverse Health and Safety Outcomes - Attentional Failures	Attentional failures (nodding off) will be self-reported on the monthly questionnaires (count per month).	Up to 9 months
Secondary	Secondary Aim 4: Health Care Costs	Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.	Up to 9 months