Aherence, Mental Health, Physical Symptoms, Quality of Life
Conditions
Keywords
Augmented Reality (AR), continuous positive airway pressure (CPAP), Adherence, Symptoms change
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.
Interventions
BEHAVIORALWith AR guided CPAP therapy
Participants will received AR training course to utilize the AR guided CPAP therapy
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactYen Chin Chen, PhD
Outcome results
None listed