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
| Registry | NCT06520592, acronym CPAP OSA |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, health services research |
| Enrollment | 60 (Estimated) |
| Sponsor | National Cheng-Kung University Hospital (Other) |
| Conditions | Aherence, Physical Symptoms, Mental Health, Quality of Life |
| Interventions | With AR guided CPAP therapy (Behavioral) |
| Dates | start 2026-09-24, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2024-07-25, last updated 2026-10-15 |
| Locations | 1 site in Taiwan |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| With AR guided CPAP therapy | Experimental | Behavioral: With AR guided CPAP therapy | OSA patientns were assigned to experimental group, they will be received 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 |
Sex: All
Inclusion Criteria: * (1) Diagnosed with moderate to severe obstructive sleep apnea (AHIā„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.
| Facility | City | Country | Status |
|---|---|---|---|
| National Cheng Kung University Hospital | Tainan, Taiwan | Taiwan |