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NOT YET RECRUITING
NCT06999746
NA

Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure

Sponsor: National Cheng-Kung University Hospital

View on ClinicalTrials.gov

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

Interventions

OTHER

Control

Sleep hygiene education

DEVICE

Oropharyngeal Exercise

Device-monitoring oropharyngeal exercise, 1-5 days a week for three months

DEVICE

Continuous positive airway pressure

Continuous positive airway pressure, 1-5 days a week for three months

DEVICE

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