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Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure
Sponsor: National Cheng-Kung University Hospital
Summary
The goal of this clinical trial is to evaluate the effectiveness of device-assisted oropharyngeal rehabilitation (OPR) in improving upper airway muscle function and reducing obstructive sleep apnea (OSA) severity in adult patients diagnosed with OSA who are receiving continuous positive airway pressure (CPAP) therapy. The main questions it aims to answer are: 1. Does combining OPR with CPAP increase upper airway space volume compared to using CPAP alone? 2. Does OPR improve tongue muscle strength, and is this improvement associated with reduced CPAP pressure requirements? 3. Do patients receiving OPR (alone or combined with CPAP) show greater improvements in OSA severity and clinical symptoms compared to those receiving CPAP alone or no intervention? Researchers will compare four groups-Control, OPR-only, CPAP-only, and CPAP + OPR-to see if device-assisted OPR enhances treatment outcomes beyond CPAP alone. Participants will: 1. Be randomly assigned to one of four groups (Control, OPR-only, CPAP-only, CPAP+OPR). 2. Perform home-based OPR exercises (30-45 minutes/session, 1-2 sessions/day, 3-5 days/week for 3 months) in the OPR and CPAP+OPR groups. 3. Have their exercise monitored using a strength sensor, with intensity adjusted every 2-4 weeks during hospital visits. 4. Undergo assessments before and after the intervention, including: (1) Polysomnography for OSA severity, (2) CT and ultrasound for upper airway and tongue muscle structure, (3) Tongue muscle strength/endurance tests, (4) Sleep quality questionnaires, (5) CPAP usage and pressure reports.
Official title: Effectiveness of Using Force Sensing Resistor to Assist Oropharyngeal Rehabilitation in Patients With Obstructive Sleep Apnea Using Continuous Positive Airway Pressure
Key Details
Gender
All
Age Range
20 Years - 68 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-06-15
Completion Date
2029-12-31
Last Updated
2025-05-31
Healthy Volunteers
No
Conditions
Interventions
Control
Sleep hygiene education
Oropharyngeal Exercise
Device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Continuous positive airway pressure
Continuous positive airway pressure, 1-5 days a week for three months
Continuous positive airway pressure and oropharyngeal exercise
Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Locations (1)
National Cheng Kung University Hospital
Tainan, Taiwan