search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
the smart watch and Samsung Health app
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smart watch group

Usual care

Arm Description

The user of the smart watch and Samsung Health app

No use of both the smart watch and Samsung Health app

Outcomes

Primary Outcome Measures

Average daily usage of PAP (all days)
Average daily usage of PAP (all days) in 90 days

Secondary Outcome Measures

Average daily usage of PAP (days used)
Average daily usage of PAP (days used) in 90 days
Percentage of days using PAP
Percentage of days using PAP
Percentage of days using PAP ≥ 4 hours
Percentage of days using PAP ≥ 4 hours
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
Changes of the scores of Epworth Sleepiness Scale
Changes of the scores of Epworth Sleepiness Scale
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)
Patient satisfaction with PAP therapy
Patient satisfaction with PAP therapy

Full Information

First Posted
September 3, 2022
Last Updated
April 11, 2023
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05530265
Brief Title
Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)
Official Title
Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult, Positive Airway Pressure, Adherence, Treatment, Smart Watch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smart watch group
Arm Type
Experimental
Arm Description
The user of the smart watch and Samsung Health app
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No use of both the smart watch and Samsung Health app
Intervention Type
Device
Intervention Name(s)
the smart watch and Samsung Health app
Intervention Description
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
Primary Outcome Measure Information:
Title
Average daily usage of PAP (all days)
Description
Average daily usage of PAP (all days) in 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Average daily usage of PAP (days used)
Description
Average daily usage of PAP (days used) in 90 days
Time Frame
90 days
Title
Percentage of days using PAP
Description
Percentage of days using PAP
Time Frame
90 days
Title
Percentage of days using PAP ≥ 4 hours
Description
Percentage of days using PAP ≥ 4 hours
Time Frame
90 days
Title
Percentage of patients meeting the National Health Insurance Service adherence criteria
Description
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
Time Frame
90 days
Title
Changes of the scores of Epworth Sleepiness Scale
Description
Changes of the scores of Epworth Sleepiness Scale
Time Frame
90 days
Title
Changes of the scores of Pittsburgh Sleep Quality Index
Description
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)
Time Frame
90 days
Title
Patient satisfaction with PAP therapy
Description
Patient satisfaction with PAP therapy
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaeyoung Cho, M.D., Ph.D.
Phone
+82-2-2072-2503
Email
apricot6@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaeyoung Cho, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaeyoung Cho, MD
Phone
82-2-2072-2503
Email
apricot6@snu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs