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Recruiting NCT05197738

Research Framework Exploring Sleep Health

— Observational Sleep Sleep Apnea Obesity Mood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sleep, Sleep Apnea, Obesity, Mood. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Scripps Research Institute — La Jolla

Identifiers

NCT: NCT05197738 · IRB-21-7863

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗