Research Framework Exploring Sleep Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorScripps Translational Science Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Residing within the United States
Ability to use the REFRESH app on the participant's own smartphone device
Disqualifiers
In-ability to consent
Trial population
General adult population.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100,000 Participants
are grouped into 11 trial groups11
Trial groupsSee each trial group below.
Group A: High risk OSA
Group B: Low risk OSA
Group C: Short sleepers
Group D: Long sleepers
Group E: Average lengths leepers
Group F: Regular sleepers
Group G: Irregular sleepers
Group H: Severe insomnia risk
Group I: Moderate insomnia risk
Group J: No insomnia risk
Group K: Increased social jet lag
Trial outcomes
Primary outcomes
1
Patient Health Questionnaire 9
Baseline depression scores on a scale from 0 to 27, which higher scores indicated more depression
Time frame
Administered one time at enrollment2
Bi-weekly mood scores
Mood scores based on an 11 point rating scale, with higher scores indicated a better mood
Time frame
Averaged bi-weekly over a two month period3
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
Time frame
Averaged bi-weekly over a two month period4
Change in BMI
Based on standard BMI categories; calculated based on self-reported data of height and weight
Time frame
Measured as the difference between BMI reported at the beginning of the study and at the two-month mark.Sponsors and contacts
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Source ClinicalTrials.gov