Sleep Initiation and Maintenance DisordersNCT04224285
Operational Trial of Dayzz App
A study testing Dayzz app in people with Sleep Initiation and Maintenance Disorders, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Dayzz app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,355 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Regularly work evening, night or rotating shifts.
- Pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Dayzz app
- Keywords
- sleep, sleep deficiency, workplace health, occupational health, workplace health promotion, mobile health, mHealth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dayzz appOther
Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Up to 9 months
Primary Aim 2: Sleep Duration
Sleep duration will be reported in the eDiary.
Measured: 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).
Measured: Up to 9 months
Secondary outcomes (14)
Secondary Aim 1: Absenteeism
Unscheduled absences and disability day usage will be collected by self-report on the monthly questionnaires.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: 1 week of daily eDiary in both Month 1 and Month 3
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.
Measured: Up to 9 months
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.
Measured: 1 week of daily eDiary in both Month 1 and Month 3
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.
Measured: Up to 9 months
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.
Measured: 1 week of daily eDiary in both Month 1 and Month 3
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).
Measured: Up to 9 months
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).
Measured: Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries
Injuries will be self-reported on the monthly questionnaires (count per month).
Measured: Up to 9 months
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).
Measured: Up to 9 months
Secondary Aim 4: Health Care Costs
Healthcare utilization will be reported on monthly surveys and costs estimated from the reported usages.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 Aug 2020
- Primary completion27 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- wait list control
- Masking
- None (open label)
- Enrolment
- 1,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura K. Barger, Brigham and Women's Hospital
- Investigators
- Rebecca Robbins, PhD, Study director, Brigham and Women's Hospital / Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224285
- Sponsor's protocol ID
- 2019P003277
- Status last verified
- Jun 2022
- First submitted
- 23 Dec 2019
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized study data will be made available upon request, consistent with our institution's IRB policies and procedures. Data and supporting documentation will become available two years following the primary publication and remain available for five years. Interested individuals will be asked to provide a research plan. Requests will be reviewed and granted as appropriate.
Publications
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.
PubMed 36104122Robbins 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.
PubMed 34986183
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Trial of Dayzz App
- ClinicalTrials.gov ID
- NCT04224285
- Acronym / sponsor ID
- 2019P003277
- Keywords
- sleep, sleep deficiency, workplace health, occupational health, workplace health promotion, mobile health, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- wait list control
| Arm | Type | Receives |
|---|---|---|
| Early Dayzz | Experimental | Other: Dayzz appParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Regularly work evening, night or rotating shifts.
- Pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dayzz appPersonalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution | Other | Early Dayzz |
Primary outcome
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.
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).
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.
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.
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).
14 secondary outcomes
Secondary Aim 1: Absenteeism
Time frame: Up to 9 months
Secondary Aim 1: Performance/Productivity - Absenteeism
Time frame: Up to 9 months
Secondary Aim 1: Performance/Productivity - Presenteeism
Time frame: Up to 9 months
Secondary Aim 2: Mood - Monthly questionnaire
Time frame: Up to 9 months
Secondary Aim 2: Mood - eDiary
Time frame: 1 week of daily eDiary in both Month 1 and Month 3
Secondary Aim 2: Alertness - Monthly questionnaire
Time frame: Up to 9 months
Secondary Aim 2: Alertness - eDiary
Time frame: 1 week of daily eDiary in both Month 1 and Month 3
Secondary Aim 2: Energy - Monthly questionnaire
Time frame: Up to 9 months
Secondary Aim 2: Energy - eDiary
Time frame: 1 week of daily eDiary in both Month 1 and Month 3
Secondary Aim 3: Adverse Health and Safety Outcomes - Motor Vehicle Crashes
Time frame: Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Near Crash Incidents
Time frame: Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Injuries
Time frame: Up to 9 months
Secondary Aim 3: Adverse Health and Safety Outcomes - Attentional Failures
Time frame: Up to 9 months
Secondary Aim 4: Health Care Costs
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 36104122Robbins 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.
- Derived from this study: PubMed 34986183Robbins 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.
- Individual participant dataSharing planned: Yes. Anonymized study data will be made available upon request, consistent with our institution's IRB policies and procedures. Data and supporting documentation will become available two years following the primary publication and remain available for five years. Interested individuals will be asked to provide a research plan. Requests will be reviewed and granted as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Robbins, PhD study director
Brigham and Women's Hospital / Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dayzz app in people with Sleep Initiation and Maintenance Disorders, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Aim 1: Sleep Behavior 1 (time frame: Up to 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224285, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.