Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

National Cheng-Kung University Hospital

Conditions:

Obstructive Sleep Apnea

Eligibility:

All Genders

20-68 years

Phase:

NA

Brief 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 (O...

Detailed Description

Background: Obstructive sleep apnea (OSA) is a common respiratory disorder associated with various complications, including cardiovascular, metabolic, and cognitive issues. Continuous positive airway ...

Eligibility Criteria

Inclusion

  • Adults aged 20 to 68 years
  • Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography

Exclusion

  • Severe allergic rhinitis
  • Sinusitis with nasal polyps
  • Adenoid hypertrophy
  • Bilateral tonsillar hypertrophy (Friedman grade ≥ III)
  • Lingual tonsil hypertrophy (Friedman grade ≥ III)
  • Body Mass Index (BMI) \> 40
  • Alcohol or drug abuse within the past year
  • Pregnancy
  • 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
  • Sleep disorders with concomitant central sleep apnea

Key Trial Info

Start Date :

June 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2029

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06999746

Start Date

June 15 2025

End Date

December 31 2029

Last Update

May 31 2025

Active Locations (1)

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National Cheng Kung University Hospital

Tainan, Taiwan, 704