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

Stanford University

Status: Enrolling

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Diagnostic Test: Samsung Galaxy Watch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06603441

76129

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Samsung Galaxy Watch technology

Description:

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

Treatment:

Diagnostic Test: Samsung Galaxy Watch