Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure
Key facts
- Where
- Tainan, TaiwanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 68 years old?
Source: NCT06999746, who can take part
Where in Taiwan
- National Cheng Kung University HospitalTainan, TaiwanContact: Ching-Hsia Hung, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National Cheng-Kung University Hospital
- Trial code
- NCT06999746
- Record updated
- 31 May 2025
- Original description
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.Read full original descriptionShow less
Effectiveness of Using Force Sensing Resistor to Assist Oropharyngeal Rehabilitation in Patients With Obstructive Sleep Apnea Using Continuous Positive Airway Pressure
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.
Inclusion: Adults aged 20 to 68 years; Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography.
Exclusion: Alcohol or drug abuse within the past year; Sleep disorders with concomitant central sleep apnea; Severe allergic rhinitis; Severe obstructive or restrictive pulmonary diseases; High-risk cardiovascular diseases during exercise (e.g., angina, myocardial infarction, heart failure, valvular heart disease); History of central or peripheral neurological disorders that interfere with exercise prescription; Musculoskeletal or psychological disorders that interfere with exercise prescription; Other non-respiratory sleep disorders; Sinusitis with nasal polyps; Adenoid hypertrophy; Bilateral tonsillar hypertrophy (Friedman grade ≥ III); Lingual tonsil hypertrophy (Friedman grade ≥ III); Body Mass Index (BMI) > 40; Pregnancy.