Research Framework Exploring Sleep Health

Obesity Clinical Trial

— REFRESH  

Official title:

Research Framework Exploring Sleep Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05197738
• Other study ID #: IRB-21-7863
• Status: Not yet recruiting
• Start date: January 15, 2022
• Est. completion date: December 31, 2041

Study information

• Verified date: January 2022
• Source: Scripps Translational Science Institute
• Contact: Stuti Jaiswal, MD, PhD
• Phone: 858-784-2169
• Email: stuti[@]scripps.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2041
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mood
• Obesity
• Sleep
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.