The Effectiveness of Augmented Reality to Enhance CPAP Therapy in OSA Patients

Not Applicable

Not yet recruiting

• Conditions: Quality of Life; Aherence; Physical Symptoms; Mental Health
• Interventions: Behavioral: With AR guided CPAP therapy

• Registration Number: NCT06520592
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Study Timeline

• Study First Submitted: 2024-07-20
• Study First Submitted QC: 2024-07-20
• Study First Posted: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With AR guided CPAP therapy	With AR guided CPAP therapy	OSA patientns were assigned to experimental group, they will be received AR guided CPAP therapy

Primary Outcome Measures

Name	Time	Method
The adherence of CPAP therapy	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.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan