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

NCT06603441 | Completed

• 1 other identifier: 76129
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• User acceptance and feasibility of Galaxy Watch technology

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

Study Arms (1)

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

Samsung Galaxy Watch DIAGNOSTIC_TEST

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

Samsung Galaxy Watch technology

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Samsung Electronics: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Study Officials

• Robson Capasso, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: December 17, 2024
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

US (1)