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Recruiting

NCT Number: NCT05197738

Research Framework Exploring Sleep Health

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.

Recruiting

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Key information

Conditions

Sleep Apnea Body Weight Dyssomnias Mood Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Research Institute

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

Stuti J Jaiswal, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ed Ramos, PhD

CONTACT

[email protected]

Stuti Jaiswal, MD, PhD

CONTACT

[email protected]

858-784-2169

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Acronym: REFRESH

Important dates

Study start
2022
Primary completion
2026
Study completion
2041
First posted
Jan 19, 2022
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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