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OpenTrials
Completed

NCT Number: NCT06603441

Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea

The study will test the reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea (OSA)

Completed

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

A prospective cohort of 150 individuals 22 years or older with a prior diagnosis or with a high likelihood of having moderate to severe OSA, screened using STOP-Bang and Epworth Sleepiness Scale questionnaires will be recruited and will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 22 years of age or older
  • High pre-test likelihood of moderate to severe obstructive sleep apnea (OSA) based on screening questionnaires (STOP-Bang and Epworth Sleepiness Scale); or prior diagnosis of moderate-severe OSA.
  • Able to provide informed consent confirmation

Exclusion criteria

  • Severe and/or other acute medical illnesses as determined by the Investigator, in particular: Cardiac conditions such as Congestive Heart Failure (CHF), atrial fibrillation, Hx of Movement disorders: Parkinson's, Tremor, Lung conditions: Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, emphysema, pulmonary fibrosis, acute episode of flu, allergies, asthma.
  • Active comorbid sleep disorders, such as severe insomnia, restless legs syndrome, Periodic Leg Movement During Sleep (PLMS), narcolepsy, idiopathic hypersomnia
  • Severe and/or unstable psychiatric disorders such as mood, anxiety, or psychotic disorders
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
  • Inability to use a Samsung Galaxy device for sleep tracking
  • Inability to have two nights in the Stanford sleep lab.
  • Participants who are pregnant
  • Tattoos or scars covering the forearm area of both hands

Treatment and study plan

Samsung Galaxy Watch

Diagnostic Test

Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters.

Primary outcomes

  1. 4% Apnea Hypopnea Index (AHI)

    Time frame: Day 1 (Visit 1), Day 5 (Visit 2)

    Assessment of the 4% Apnea Hypopnea Index to determine the severity of sleep apnea

Secondary outcomes

  1. User acceptance and feasibility of Galaxy Watch technology

    Time frame: Day 1 (Visit 1), Day 5 (Visit 2), At home monitoring (Day 2, 3 &4)

    Evaluation of,

    • Ease of use (scored from 1-5, where 1 indicates low ease of use and 5 indicates high ease of use)
    • Comfort (scored from 1-5, where 1 indicates low comfort and 5 indicates high comfort)
    • Compliance (dropout rate and the number of nights and hours of sleep recorded for each participant)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Samsung Electronics

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Apr 15, 2026

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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