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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tainan, , Taiwan
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