Obstructive Sleep Apnea of AdultNCT05530265
Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)
A study testing the smart watch and Samsung Health app in people with Obstructive Sleep Apnea of Adult and Positive Airway Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Continuous positive airway pressure (CPAP) is highly effective in treating obstructive sleep apnea (OSA). However, this treatment modality relies heavily on patient adherence, and poor adherence to the treatment limits its effectiveness in treating OSA. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Positive Airway Pressure, Adherence, Treatment
- What is being tested?
- the smart watch and Samsung Health app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2022to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with OSA (apnea-hyponea index [AHI])≥ 5 /h) by type 1 polysomnography
- no prior use of PAP (CPAP or auto-adjusting PAP [APAP]), or no prior use of PAP within the previous 90 days in patients who had received PAP therapy, or current PAP users with average daily usage (all days) < 4 hours within the previous 90 days
Who cannot join
- patients who refuse PAP therapy
- patients who have used a smart watch (e.g., Galaxy Watch, Apple Watch, etc.) within the previous 90 days
- patients with central sleep apnea or neuromuscular disease
- patients receiving supplemental oxygen therapy due to underlying diseases including heart failure, stroke, chronic obstructive pulmonary disease, interstitial pulmonary disease, hypoventilation syndrome, or whose baseline oxygen saturation is less than 90%
- patients with implanted cardiac pacemakers, defibrillators, or other electronic devices
- patients who are inexperienced in using smartphones, apps, or smart watches
- patients with an inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
Continuous positive airway pressure (CPAP) is highly effective in treating obstructive sleep apnea (OSA). However, this treatment modality relies heavily on patient adherence, and poor adherence to the treatment limits its effectiveness in treating OSA. Strategies to augment adherence are needed in the management of OSA.
The smart watch and linked app provide various health information, including sleep, snoring or oxygen saturation during sleep, exercise, blood pressure, and electrocardiogram. The smart watch and linked app could potentially improve adherence to positive airway pressure (PAP) treatment.
This randomized controlled trial (RCT) aimed to examine whether the use of smart watch and app can increase PAP adherence in patients with OSA.
- Conditions
- Obstructive Sleep Apnea of Adult, Positive Airway Pressure, Adherence, Treatment, Smart Watch
- Being tested
- the smart watch and Samsung Health app
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the smart watch and Samsung Health appDevice
Use the smart watch (Galaxy Watch 4, Samsung Electronics Co., Ltd., Korea) and the Samsung Health app (Samsung Electronics Co., Ltd., Korea) for 90 days of positive airway pressure treatment
| Study group | Role | What they receive |
|---|---|---|
| Smart watch group | Experimental | The user of the smart watch and Samsung Health app Receives: Device: the smart watch and Samsung Health app |
| Usual care | No intervention | No use of both the smart watch and Samsung Health app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily usage of PAP (all days)
Average daily usage of PAP (all days) in 90 days
Measured: 90 days
Secondary outcomes (7)
Average daily usage of PAP (days used)
Average daily usage of PAP (days used) in 90 days
Measured: 90 days
Percentage of days using PAP
Percentage of days using PAP
Measured: 90 days
Percentage of days using PAP ≥ 4 hours
Percentage of days using PAP ≥ 4 hours
Measured: 90 days
Percentage of patients meeting the National Health Insurance Service adherence criteria
The National Health Insurance Service adherence criteria: ≥ 4 hours of use on ≥ 70% of days over 30 consecutive days during the 90 days of PAP therapy
Measured: 90 days
Changes of the scores of Epworth Sleepiness Scale
Changes of the scores of Epworth Sleepiness Scale
Measured: 90 days
Changes of the scores of Pittsburgh Sleep Quality Index
Changes of the scores of Pittsburgh Sleep Quality Index (an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality)
Measured: 90 days
Patient satisfaction with PAP therapy
Patient satisfaction with PAP therapy
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start22 Aug 2022
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
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
- NCT05530265
- Sponsor's protocol ID
- 22070571340
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05530265
- Acronym / sponsor ID
- 22070571340
- Conditions
- Obstructive Sleep Apnea of Adult, Positive Airway Pressure, Adherence, Treatment, Smart Watch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 7 Sep 2022 (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.
Continuous positive airway pressure (CPAP) is highly effective in treating obstructive sleep apnea (OSA). However, this treatment modality relies heavily on patient adherence, and poor adherence to the treatment limits its effectiveness in treating OSA. Strategies to augment adherence are needed in the management of OSA.
The smart watch and linked app provide various health information, including sleep, snoring or oxygen saturation during sleep, exercise, blood pressure, and electrocardiogram. The smart watch and linked app could potentially improve adherence to positive airway pressure (PAP) treatment.
This randomized controlled trial (RCT) aimed to examine whether the use of smart watch and app can increase PAP adherence in patients with OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart watch group | Experimental | Device: the smart watch and Samsung Health appThe user of the smart watch and Samsung Health app |
| Usual care | No intervention | –No use of both the smart watch and Samsung Health app |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with OSA (apnea-hyponea index [AHI])≥ 5 /h) by type 1 polysomnography
- no prior use of PAP (CPAP or auto-adjusting PAP [APAP]), or no prior use of PAP within the previous 90 days in patients who had received PAP therapy, or current PAP users with average daily usage (all days) < 4 hours within the previous 90 days
Key exclusion criteria (7 listed)
- patients who refuse PAP therapy
- patients who have used a smart watch (e.g., Galaxy Watch, Apple Watch, etc.) within the previous 90 days
- patients with central sleep apnea or neuromuscular disease
- patients receiving supplemental oxygen therapy due to underlying diseases including heart failure, stroke, chronic obstructive pulmonary disease, interstitial pulmonary disease, hypoventilation syndrome, 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 |
|---|---|---|
| the smart watch and Samsung Health appUse the smart watch (Galaxy Watch 4, Samsung Electronics Co., Ltd., Korea) and the Samsung Health app (Samsung Electronics Co., Ltd., Korea) for 90 days of positive airway pressure treatment | Device | Smart watch group |
Primary outcome
Average daily usage of PAP (all days)
Time frame: 90 days
Average daily usage of PAP (all days) in 90 days
7 secondary outcomes
Average daily usage of PAP (days used)
Time frame: 90 days
Percentage of days using PAP
Time frame: 90 days
Percentage of days using PAP ≥ 4 hours
Time frame: 90 days
Percentage of patients meeting the National Health Insurance Service adherence criteria
Time frame: 90 days
Changes of the scores of Epworth Sleepiness Scale
Time frame: 90 days
Changes of the scores of Pittsburgh Sleep Quality Index
Time frame: 90 days
Patient satisfaction with PAP therapy
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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. This study is not recruiting at the moment.
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?
A study testing the smart watch and Samsung Health app in people with Obstructive Sleep Apnea of Adult and Positive Airway Pressure, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 24 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily usage of PAP (all days) (time frame: 90 days). 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 24 Apr 2026.