NCT05197738 · Scripps Translational Science Institute
Research Framework Exploring Sleep Health
(REFRESH)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Patient Health Questionnaire 9
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Jolla, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 28, 2024 · Source of record for eligibility and locations