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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-68
SponsorNational Cheng-Kung University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 20 to 68 years

Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography

Disqualifiers

Severe allergic rhinitis

Sinusitis with nasal polyps

Adenoid hypertrophy

Bilateral tonsillar hypertrophy (Friedman grade ≥ III)

Trial design

Treatments tested in this trial

  • Control
  • Oropharyngeal Exercise
  • Continuous positive airway pressure
  • Continuous positive airway pressure and oropharyngeal exercise

Treatment groups

200 Participants
are divided into 4 treatment groups