Obstructive Sleep Apnea of AdultNCT06792188
Smartwatch-Based AI Model for OSA Prediction (SWOSA)
An observational study of Obstructive Sleep Apnea of Adult and Screening, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Screening, Smart Watch
- What is being tested?
- Galaxy Watch 4, Samsung Electronics Co., Ltd., South Korea
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jaeyoung Cho, MD, 82-2-2072-2503, apricot6@snu.ac.kr
About this study
Official title: Smartwatch-Based Artificial Intelligence Model for Obstructive Sleep Apnea Prediction
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.
- Conditions
- Obstructive Sleep Apnea of Adult, Screening, Smart Watch
- Being tested
- Galaxy Watch 4, Samsung Electronics Co., Ltd., South Korea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galaxy Watch 4, Samsung Electronics Co., Ltd., South KoreaDevice
Use of the Galaxy Watch 4 during sleep for approximately two weeks prior to the polysomnography test, including the night of the test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Galaxy Watch 4, Samsung Electronics Co., Ltd., South Korea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Accuracy of the AI Model for Moderate-to-Severe Obstructive Sleep Apnea
Evaluation of how well the AI model, developed using clinical data and smartwatch-recorded information including nocturnal oxygen saturation, predicts moderate-to-severe obstructive sleep apnea (defined as apnea-hypopnea index ≥15/hour) diagnosed by polysomnography.
Measured: Up to 2 weeks prior to the polysomnography test.
Secondary outcomes (3)
Predictive Accuracy of the Galaxy Watch Sleep Apnea Feature (SAF)
Assessment of the accuracy of the Galaxy Watch's built-in sleep apnea feature (SAF) in predicting moderate-to-severe obstructive sleep apnea diagnosed by polysomnography.
Measured: Up to 2 weeks prior to the polysomnography test.
Comparison of AI Model and Galaxy Watch Sleep Apnea Feature (SAF) Performance
Comparison of the predictive performance between the AI model developed in this study and the Galaxy Watch's built-in sleep apnea feature (SAF) for detecting moderate-to-severe obstructive sleep apnea.
Measured: Up to 2 weeks prior to the polysomnography test.
Comparison of AI Model and STOP-Bang Questionnaire Performance
Comparison of the predictive performance between the AI model developed in this study and the STOP-Bang questionnaire for detecting moderate-to-severe obstructive sleep apnea.
Measured: Up to 2 weeks prior to the polysomnography test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start3 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaeyoung Cho, Seoul National University Hospital
- Investigators
- Jaeyoung Cho, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792188
- Sponsor's protocol ID
- 24111291590
- Status last verified
- May 2025
- First submitted
- 19 Jan 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that support the findings of this study
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartwatch-Based Artificial Intelligence Model for Obstructive Sleep Apnea Prediction
- ClinicalTrials.gov ID
- NCT06792188
- Acronym / sponsor ID
- 24111291590
- Conditions
- Obstructive Sleep Apnea of Adult, Screening, Smart Watch
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart Watch Group | – | Device: Galaxy Watch 4, Samsung Electronics Co., Ltd., South KoreaMen 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. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galaxy Watch 4, Samsung Electronics Co., Ltd., South KoreaUse of the Galaxy Watch 4 during sleep for approximately two weeks prior to the polysomnography test, including the night of the test. | Device | Smart Watch Group |
Primary outcome
Predictive Accuracy of the AI Model for Moderate-to-Severe Obstructive Sleep Apnea
Time frame: Up to 2 weeks prior to the polysomnography test.
Evaluation of how well the AI model, developed using clinical data and smartwatch-recorded information including nocturnal oxygen saturation, predicts moderate-to-severe obstructive sleep apnea (defined as apnea-hypopnea index ≥15/hour) diagnosed by polysomnography.
3 secondary outcomes
Predictive Accuracy of the Galaxy Watch Sleep Apnea Feature (SAF)
Time frame: Up to 2 weeks prior to the polysomnography test.
Comparison of AI Model and Galaxy Watch Sleep Apnea Feature (SAF) Performance
Time frame: Up to 2 weeks prior to the polysomnography test.
Comparison of AI Model and STOP-Bang Questionnaire Performance
Time frame: Up to 2 weeks prior to the polysomnography test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that support the findings of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaeyoung Cho, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult and Screening, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaeyoung Cho, M.D., Ph.D. (+82-2-2072-2503, apricot6@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Accuracy of the AI Model for Moderate-to-Severe Obstructive Sleep Apnea (time frame: Up to 2 weeks prior to the polysomnography test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.