Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)

NCT ID: NCT05530265

Last Updated: 2024-04-17

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

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea of Adult Positive Airway Pressure Adherence, Treatment Smart Watch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Smart watch group

The user of the smart watch and Samsung Health app

Group Type EXPERIMENTAL

the smart watch and Samsung Health app

Intervention Type DEVICE

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

Usual care

No use of both the smart watch and Samsung Health app

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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the smart watch and Samsung Health app

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

22 Years

Maximum Eligible Age

75 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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22070571340

Identifier Type: -

Identifier Source: org_study_id

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