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CompletedNCT06603441Updated Apr 15, 2026

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

An observational study in Obstructive Sleep Apnea of Adult, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
152
Ages
22 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Obstructive Sleep Apnea of Adult
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. Patient's visiting Stanford Hospital and Clinics
  2. Digital Recruitment - online advertisement campaign

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
152 participants (actual)
Patient registry
No

Groups and cohorts

  • Samsung Galaxy Watch technology

    All participants screened 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

    Diagnostic Test: Samsung Galaxy Watch

Interventions

  • Diagnostic testSamsung Galaxy Watch

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

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What researchers measure

Primary outcomes

  1. 4% Apnea Hypopnea Index (AHI)

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

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

Secondary outcomes

  1. User acceptance and feasibility of Galaxy Watch technology

    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)

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

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Study locations

1 site
  • Stanford University
    Palo Alto, California 94305, United States
08

References and documents

Publications

  • Alavi A, Costa E, Matsumoto MMS, Odenwald N, Kushida C, Bahmani A, Capasso R. Comprehensive Evaluation of Night-to-Night Variability in Polysomnography Metrics and Apnea-Hypopnea Index-Based Diagnostic Reclassification. Chest. 2026 Jun 16:S0012-3692(26)00782-8. doi: 10.1016/j.chest.2026.06.004. Online ahead of print. PubMed 42302984 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06603441
Lead sponsor
Stanford University
Collaborators
Samsung Electronics
Responsible party
Robson Capasso (Professor of Otolaryngology - Head & Neck Surgery (OHNS), Stanford University) — Principal investigator
First posted
Sep 19, 2024
Start date
Dec 17, 2024
Primary completion
Dec 23, 2025
Completion
Dec 23, 2025
Last update
Apr 15, 2026

Study contacts

Robson Capasso, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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