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)

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Diagnostic test: Samsung Galaxy Watch

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.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4% Apnea Hypopnea Index (AHI)	Assessment of the 4% Apnea Hypopnea Index to determine the severity of sleep apnea	Day 1 (Visit 1), Day 5 (Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1 (Visit 1), Day 5 (Visit 2), At home monitoring (Day 2, 3 &4)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Robson Capasso, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Actual): December 23, 2025
• Study Completion (Actual): December 23, 2025

Study Registration Dates

• First Submitted: September 7, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 76129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No