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Clinical Trials/NCT06520592
NCT06520592
Not yet recruiting
Not Applicable

Using Augmented Reality to Establish and Evaluate the Effectiveness of a Set of Continuous Positive Airway Pressure Care Management Protocol for Obstructive Sleep Apnea Patients

National Cheng-Kung University Hospital1 site in 1 country60 target enrollmentJune 20, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aherence
Sponsor
National Cheng-Kung University Hospital
Enrollment
60
Locations
1
Primary Endpoint
The adherence of CPAP therapy
Status
Not yet recruiting
Last Updated
11 months ago

Overview

Brief Summary

The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:

Does AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.

Participants will:

  1. Take AR guided CPAP therapy or standard of care every day for 6 months
  2. Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).
  3. Response their symptoms on each following time.

Detailed Description

Participants will randomly assign to two group, for experimental group will be received AR guided CPAP therapy. In the control group will be received standard of care.

Registry
clinicaltrials.gov
Start Date
June 20, 2025
End Date
July 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chen, Yen-Chin

Associate Professor

National Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • (1) Diagnosed with moderate to severe obstructive sleep apnea (AHI≥15) through polysomnography (PSG).
  • (2) Age is equal to or greater than 20 years old or equal.

Exclusion Criteria

  • (1) individuals who have previously used positive pressure ventilators for treatment,
  • (2) those diagnosed with central sleep apnea,
  • (3) those with uncontrolled acute mental illness,
  • (4) terminally ill patients.

Outcomes

Primary Outcomes

The adherence of CPAP therapy

Time Frame: From enrollment to the end of treatment at 6 months

Adherence refers to the patient's adherence to CPAP therapy, which means using CPAP for more than 70% of the total sleep time during the night, with a minimum duration of 4 hours. The calculation method involves dividing the number of days with CPAP use exceeding 4 hours by the total number of days and multiplying by 100 to obtain the average percentage of CPAP usage.

Study Sites (1)

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