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Search / Trial NCT06999746

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

Launched by NATIONAL CHENG-KUNG UNIVERSITY HOSPITAL · May 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help adults with obstructive sleep apnea (OSA), a condition where a person's breathing repeatedly stops and starts during sleep. The study is looking at whether combining a special exercise program, called device-assisted oropharyngeal rehabilitation (OPR), with continuous positive airway pressure (CPAP) therapy can improve breathing and reduce the severity of OSA more effectively than using CPAP alone. Researchers will compare four different groups: those receiving only CPAP, those doing only OPR exercises, those getting both treatments, and a control group with no intervention.

To participate, individuals should be adults aged 20 to 68 who have been newly diagnosed with mild to severe OSA. They should not have certain medical conditions that could complicate the study, such as severe allergies, significant obesity, or certain heart and neurological issues. Participants will be assigned to one of the four groups and will perform home-based OPR exercises for about 30-45 minutes, 1-2 times a day, for three months. Throughout the study, their progress will be monitored, and they will undergo various assessments to measure improvements in sleep quality and muscle function. This trial aims to find out if this combined approach can lead to better outcomes for patients managing OSA.

Gender

ALL

Eligibility criteria

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

About National Cheng Kung University Hospital

National Cheng Kung University Hospital is a leading academic medical institution in Taiwan, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources and expertise in various medical fields to facilitate groundbreaking studies that enhance patient care and medical knowledge. Committed to adhering to the highest ethical standards and regulatory guidelines, National Cheng Kung University Hospital fosters collaborations with researchers, healthcare professionals, and industry partners to drive the development of new therapies and improve health outcomes for diverse populations.

Locations

Tainan, , Taiwan

Patients applied

0 patients applied

Trial Officials

Ching-Hsia Hung, PhD

Principal Investigator

National Cheng Kung University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported