Clinical trial NCT06603441: Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea
Official title: Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patient's visiting Stanford Hospital and Clinics
2. Digital Recruitment - online advertisement campaign

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 4% Apnea Hypopnea Index (AHI)
timeFrame: Day 1 (Visit 1), Day 5 (Visit 2)
Secondary outcomes:
measure: User acceptance and feasibility of Galaxy Watch technology
timeFrame: Day 1 (Visit 1), Day 5 (Visit 2), At home monitoring (Day 2, 3 &4)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Robson Capasso, MD
role: PRINCIPAL_INVESTIGATOR
References: