Smartwatch-Based AI Model for OSA Prediction (SWOSA)

NCT ID: NCT06792188

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-12-31

Brief Summary

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This study aims to develop an artificial intelligence (AI) model for more accurately diagnosing obstructive sleep apnea (OSA) by collecting blood oxygen saturation and other health information during sleep using a smartwatch.

OSA is common but often underdiagnosed, and the gold-standard diagnostic test, polysomnography, is costly and time-consuming. Smartwatches can provide a variety of health data, such as sleep patterns, blood oxygen saturation, and heart rate, which can help detect key symptoms and signs of OSA.

By developing an AI model that uses smartwatch data to screen for OSA, this study seeks to offer a cost-effective and accessible diagnostic method, ultimately contributing to the early detection and improved treatment rates of OSA.

Detailed Description

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Conditions

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Obstructive Sleep Apnea of Adult Screening Smart Watch

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Smart Watch Group

Men and women aged 22 to 85 years who visited Seoul National University Hospital with suspected sleep apnea due to symptoms such as snoring, apnea, or excessive daytime.

Galaxy Watch 4, Samsung Electronics Co., Ltd., South Korea

Intervention Type DEVICE

Use of the Galaxy Watch 4 during sleep for approximately two weeks prior to the polysomnography test, including the night of the test.

Interventions

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Galaxy Watch 4, Samsung Electronics Co., Ltd., South Korea

Use of the Galaxy Watch 4 during sleep for approximately two weeks prior to the polysomnography test, including the night of the test.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 22 to 85 years who visited Seoul National University Hospital with suspected sleep apnea due to symptoms such as snoring, apnea, or excessive daytime sleepiness.

Exclusion Criteria

* Patients previously diagnosed with sleep apnea who are currently undergoing treatment (e.g., positive airway pressure \[PAP\] therapy, mechanical ventilation, oral appliances, or surgery).
* Patients with neuromuscular diseases or a history of chronic opioid medication use.
* Patients with severe insomnia that is not controlled by medication.
* Patients receiving supplemental oxygen therapy due to underlying conditions such as heart failure, chronic obstructive pulmonary disease, interstitial lung disease, hypoventilation syndrome, or stroke, or whose baseline oxygen saturation is less than 90%.
* Patients with implanted cardiac pacemakers, defibrillators, or other electronic devices.
* Patients inexperienced in using smartphones, apps, or smartwatches.
* Pregnant women.
* Patients unable or unwilling to provide written informed consent.
Minimum Eligible Age

22 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jaeyoung Cho

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaeyoung Cho, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jaeyoung Cho, M.D., Ph.D.

Role: CONTACT

+82-2-2072-2503

Facility Contacts

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Jaeyoung Cho, MD

Role: primary

82-2-2072-2503

Other Identifiers

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24111291590

Identifier Type: -

Identifier Source: org_study_id

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