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

NCT06520592 | Not Yet Recruiting DMC

• 2 other identifiers: A-ER-111-531112-2628-B-110 -006 -MY3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Take AR guided CPAP therapy or standard of care every day for 6 months
2. 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. 3.Response their symptoms on each following time.

Conditions

Aherence; Physical Symptoms; Mental Health; Quality of Life

Keywords

Augmented Reality (AR); continuous positive airway pressure (CPAP); Adherence; Symptoms change

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

With AR guided CPAP therapy

EXPERIMENTAL

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

Behavioral: With AR guided CPAP therapy

Standard of care

NO INTERVENTION

OSA patientns were assigned to stand of care group, they will be not received AR guided CPAP therapy

Interventions

With AR guided CPAP therapy BEHAVIORAL

Participants will received AR training course to utilize the AR guided CPAP therapy

With AR guided CPAP therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 70403, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 27542595 BACKGROUND

• 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.

  PMID: 30684472 BACKGROUND

• 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.

  PMID: 32150700 BACKGROUND

• Chen MC, Chen YC, Lin CY. Enhancing Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Using Augmented Reality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 6;14:e69757. doi: 10.2196/69757.

  PMID: 40327384 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Yen Chin Chen, PhD

CONTACT

886-7-5252000; yenchin2427@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participnants will be randomly assigned to experimental or control groups by using block randomized method. In the study, we will use independent staff members who are not involved in outcome assessment to handle administrative tasks related to group assignments. In order to mask outcomes assessors, we will ensure that all documents and data sets used by the outcome assessors do not contain any information that could reveal group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: For the interventional group, they will utilize AR-guided CPAP therapy to ensure a proper fit of the CPAP device mask and successful adherence to the CPAP therapy. For the standard of care group, they will receive the standard of care.

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: June 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: July 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)