Research Framework Exploring Sleep Health

Recruiting

• Conditions: Sleep; Obesity; Sleep Apnea; Mood

• Registration Number: NCT05197738
• Lead Sponsor: Scripps Translational Science Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-19
• Study Start: 2022-02-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2026-12-31
• Study Completion: 2041-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Scripps Research Institute; 🇺🇸 La Jolla, California, United States