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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Mental Health; Physical Symptoms; Aherence
• Intervention / Treatment: Behavioral: With AR guided CPAP therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen Chin Chen, PhD; Phone Number: 3714 886-7-5252000; Email: yenchin2427@gmail.com

Study Locations

• Taiwan
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
    • Contact: Ting-Tsung Chang, MD; Phone Number: 3635 886-6-2353535; Email: em73635@mail.hosp.ncku.edu.tw
    • Contact: Chen; Phone Number: 0963412677; Email: yenchin2427@gmail.com
    • Principal Investigator: Yen-Chin Chen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With AR guided CPAP therapy; OSA patientns were assigned to experimental group, they will be received AR guided CPAP therapy	Behavioral: With AR guided CPAP therapy; Participants will received AR training course to utilize the AR guided CPAP therapy
No Intervention: Standard of care; OSA patientns were assigned to stand of care group, they will be not received AR guided CPAP therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The adherence of CPAP therapy	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.	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.
• Bakker JP, Weaver TE, Parthasarathy S, Aloia MS. Adherence to CPAP: What Should We Be Aiming For, and How Can We Get There? Chest. 2019 Jun;155(6):1272-1287. doi: 10.1016/j.chest.2019.01.012. Epub 2019 Jan 23.
• Wiederhold BK. How Virtual Reality Is Changing the Reality of Aging. Cyberpsychol Behav Soc Netw. 2020 Mar;23(3):141-142. doi: 10.1089/cyber.2020.29176.bkw. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; continuous positive airway pressure (CPAP); Augmented Reality (AR); Symptoms change
• Other Study ID Numbers: A-ER-111-531; 112-2628-B-110 -006 -MY3 (Other Grant/Funding Number: National Science and Technology Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No