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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aherence Physical Symptoms Mental Health Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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With AR guided CPAP therapy

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

Group Type EXPERIMENTAL

With AR guided CPAP therapy

Intervention Type BEHAVIORAL

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

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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With AR guided CPAP therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No