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Trial record 1 of 1 for:    NCT05530265
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Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)

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ClinicalTrials.gov Identifier: NCT05530265
Recruitment Status : Recruiting
First Posted : September 7, 2022
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Jaeyoung Cho, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE September 3, 2022
First Posted Date  ICMJE September 7, 2022
Last Update Posted Date April 17, 2024
Actual Study Start Date  ICMJE August 22, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2022)		 Average daily usage of PAP (all days) [ Time Frame: 90 days ]
Average daily usage of PAP (all days) in 90 days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2023)
  • Average daily usage of PAP (days used) [ Time Frame: 90 days ]
    Average daily usage of PAP (days used) in 90 days
  • Percentage of days using PAP [ Time Frame: 90 days ]
    Percentage of days using PAP
  • Percentage of days using PAP ≥ 4 hours [ Time Frame: 90 days ]
    Percentage of days using PAP ≥ 4 hours
  • Percentage of patients meeting the National Health Insurance Service adherence criteria [ Time Frame: 90 days ]
    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 [ Time Frame: 90 days ]
    Changes of the scores of Epworth Sleepiness Scale
  • Changes of the scores of Pittsburgh Sleep Quality Index [ Time Frame: 90 days ]
    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 [ Time Frame: 90 days ]
    Patient satisfaction with PAP therapy
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2022)
  • Average daily usage of PAP (days used) [ Time Frame: 90 days ]
    Average daily usage of PAP (days used) in 90 days
  • Percentage of days using PAP [ Time Frame: 90 days ]
    Percentage of days using PAP
  • Percentage of days using PAP ≥ 4 hours [ Time Frame: 90 days ]
    Percentage of days using PAP ≥ 4 hours
  • Percentage of patients meeting the National Health Insurance Service adherence criteria [ Time Frame: 90 days ]
    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 [ Time Frame: 90 days ]
    Changes of the scores of Epworth Sleepiness Scale
  • Changes of the scores of Pittsburgh Sleep Quality Index [ Time Frame: 90 days ]
    Changes of the scores of Pittsburgh Sleep Quality Index
  • Patient satisfaction with PAP therapy [ Time Frame: 90 days ]
    Patient satisfaction with PAP therapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)
Official Title  ICMJE Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea of Adult
  • Positive Airway Pressure
  • Adherence, Treatment
  • Smart Watch
Intervention  ICMJE Device: 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
Study Arms  ICMJE
  • Experimental: Smart watch group
    The user of the smart watch and Samsung Health app
    Intervention: Device: the smart watch and Samsung Health app
  • No Intervention: Usual care
    No use of both the smart watch and Samsung Health app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2022)		 92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jaeyoung Cho, M.D., Ph.D. +82-2-2072-2503 apricot6@snu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05530265
Other Study ID Numbers  ICMJE 22070571340
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jaeyoung Cho, Seoul National University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seoul National University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaeyoung Cho, M.D., Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP