Research Framework Exploring Sleep Health

Study Overview
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Brief Summary
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This is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.

Official Title
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Research Framework Exploring Sleep Health

Conditions
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Sleep, Sleep Apnea, Obesity, Mood

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Residing within the United States Ability to use the REFRESH app on the participant's own smartphone device Exclusion Criteria: In-ability to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk OSA<br>Cohort of individuals found to sleep have scores categorized as High risk, on the Berlin questionnaire. | |
| Low risk OSA<br>Cohort of individuals found to sleep have scores categorized as Low risk, on the Berlin questionnaire. | |
| Short sleepers<br>Cohort of individuals found to have average sleep duration of < 7 hours per night. Individuals who sleep on average less than 6 hours per night will further be sub-categorized as very short sleeprs. | |
| Long sleepers<br>Cohort of individuals found to have average sleep duration of >9 hours per night. | |
| Average lengths leepers<br>Cohort of individuals found to have an average sleep duration between 7 and 9 hours per night | |
| Regular sleepers<br>Cohort of individuals whose standard deviation of sleep duration falls within 1 standard deviation of their mean sleep duration. | |
| Irregular sleepers<br>Cohort of individuals whose standard deviation of sleep duration falls greater than 1 standard deviation of their mean sleep duration | |
| Severe insomnia risk<br>Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as severe | |
| Moderate insomnia risk<br>Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as moderate | |
| No insomnia risk<br>Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as low | |
| Increased social jet lag<br>Individuals who are more than 1 hour less or more of sleep on weekdays compared to average weekend sleep. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 | Baseline depression scores on a scale from 0 to 27, which higher scores indicated more depression | Administered one time at enrollment | 
| Bi-weekly mood scores | Mood scores based on an 11 point rating scale, with higher scores indicated a better mood | Averaged bi-weekly over a two month period | 
| Subjective sleep quality | Biweekly assessment of refreshing sleep quality on an 11 point rating scale, with higher scores indicated better subjective sleep from the participant | Averaged bi-weekly over a two month period | 
| Change in BMI | Based on standard BMI categories; calculated based on self-reported data of height and weight | Measured as the difference between BMI reported at the beginning of the study and at the two-month mark. |