REFRESH: Research Framework Exploring Sleep Health
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High risk OSA Cohort of individuals found to sleep have scores categorized as "High risk," on the Berlin questionnaire. |
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| Low risk OSA Cohort of individuals found to sleep have scores categorized as "Low risk," on the Berlin questionnaire. |
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| Short sleepers 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. |
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| Long sleepers Cohort of individuals found to have average sleep duration of >9 hours per night. |
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| Average lengths leepers Cohort of individuals found to have an average sleep duration between 7 and 9 hours per night |
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| Regular sleepers Cohort of individuals whose standard deviation of sleep duration falls within 1 standard deviation of their mean sleep duration. |
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| Irregular sleepers Cohort of individuals whose standard deviation of sleep duration falls greater than 1 standard deviation of their mean sleep duration |
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| Severe insomnia risk Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as severe |
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| Moderate insomnia risk Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as moderate |
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| No insomnia risk Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as low |
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| Increased social jet lag Individuals who are more than 1 hour less or more of sleep on weekdays compared to average weekend sleep. |
Outcome Measures
Primary Outcome Measures
- Patient Health Questionnaire 9 [Administered one time at enrollment]
Baseline depression scores on a scale from 0 to 27, which higher scores indicated more depression
- Bi-weekly mood scores [Averaged bi-weekly over a two month period]
Mood scores based on an 11 point rating scale, with higher scores indicated a better mood
- Subjective sleep quality [Averaged bi-weekly over a two month period]
Biweekly assessment of refreshing sleep quality on an 11 point rating scale, with higher scores indicated better subjective sleep from the participant
- Change in BMI [Measured as the difference between BMI reported at the beginning of the study and at the two-month mark.]
Based on standard BMI categories; calculated based on self-reported data of height and weight
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Residing within the United States
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Ability to use the REFRESH app on the participant's own smartphone device
Exclusion Criteria:
- In-ability to consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Scripps Translational Science Institute
Investigators
- Principal Investigator: Stuti Jaiswal, MD, PhD, Scripps Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-21-7863