Recruiting

Observational Study

Sponsor:

Scripps Translational Science Institute

Code:

NCT05197738

Conditions

Sleep

Sleep Apnea

Obesity

Mood

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Sleep

Sleep Apnea

Obesity

Mood

Study ID

NCT05197738

Start date

Feb 15, 2022

Status verified date

Jun, 2024

Completion date

Dec 31, 2041

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

High risk OSA

Cohort of individuals found to sleep have scores categorized as "High risk," on the Berlin questionnaire.

Low risk OSA

Cohort of individuals found to sleep have scores categorized as "Low risk," on the Berlin questionnaire.

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.

Long sleepers

Cohort of individuals found to have average sleep duration of >9 hours per night.

Average lengths leepers

Cohort of individuals found to have an average sleep duration between 7 and 9 hours per night

Regular sleepers

Cohort of individuals whose standard deviation of sleep duration falls within 1 standard deviation of their mean sleep duration.

Irregular sleepers

Cohort of individuals whose standard deviation of sleep duration falls greater than 1 standard deviation of their mean sleep duration

Severe insomnia risk

Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as severe

Moderate insomnia risk

Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as moderate

No insomnia risk

Cohort of individuals whose scores on the Insomnia Severity Index would be categorized as low

Increased social jet lag

Individuals who are more than 1 hour less or more of sleep on weekdays compared to average weekend sleep.

Primary outcome measure

  • Patient Health Questionnaire 9 [ Time Frame: Administered one time at enrollment ]
  • Bi-weekly mood scores [ Time Frame: Averaged bi-weekly over a two month period ]
  • Subjective sleep quality [ Time Frame: Averaged bi-weekly over a two month period ]
  • Change in BMI [ Time Frame: Measured as the difference between BMI reported at the beginning of the study and at the two-month mark. ]

Central Contacts and Locations

Central contacts

Stuti Jaiswal, MD, PhD

858-784-2169stuti@scripps.edu

Ed Ramos, PhD

eramos@scripps.edu

Locations

Scripps Research Institute

Recruiting

La Jolla, California, United States, 92037

More Information

Sponsor

Scripps Translational Science Institute

Last update posted

Jun 28, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Translational Science Institute on 2024-06-28.