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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Positive Airway Pressure Adherence, Treatment Smart Watch Device: the smart watch and Samsung Health app Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
Actual Study Start Date : August 22, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Smart watch group
The user of the smart watch and Samsung Health app
 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
No Intervention: Usual care
No use of both the smart watch and Samsung Health app


Outcome Measures
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Primary Outcome Measures :
  1. Average daily usage of PAP (all days) [ Time Frame: 90 days ]
    Average daily usage of PAP (all days) in 90 days


Secondary Outcome Measures :
  1. Average daily usage of PAP (days used) [ Time Frame: 90 days ]
    Average daily usage of PAP (days used) in 90 days

  2. Percentage of days using PAP [ Time Frame: 90 days ]
    Percentage of days using PAP

  3. Percentage of days using PAP ≥ 4 hours [ Time Frame: 90 days ]
    Percentage of days using PAP ≥ 4 hours

  4. 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

  5. Changes of the scores of Epworth Sleepiness Scale [ Time Frame: 90 days ]
    Changes of the scores of Epworth Sleepiness Scale

  6. 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)

  7. Patient satisfaction with PAP therapy [ Time Frame: 90 days ]
    Patient satisfaction with PAP therapy


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05530265


Contacts
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Contact: Jaeyoung Cho, M.D., Ph.D. +82-2-2072-2503 apricot6@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Jaeyoung Cho, MD    82-2-2072-2503    apricot6@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jaeyoung Cho, M.D., Ph.D. Seoul National University Hospital
More Information
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Responsible Party: Jaeyoung Cho, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05530265    
Other Study ID Numbers: 22070571340
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases