Actively Recruiting
Combining Sonography to Explore the Therapeutic Effect and Mechanism of a Comprehensive Respiratory Training Exercise Program on Cardiorespiratory Endurance and Airway Muscle Function in Obstructive Sleep Apnea
Led by National Cheng-Kung University Hospital · Updated on 2025-06-18
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a comprehensive respiratory training exercise program for adults aged 20 to 65 years who have been newly diagnosed with obstructive sleep apnea (OSA). OSA involves partial or complete airway collapse during sleep, which can increase risks of cardiovascular and kidney diseases. The study aims to assess how this training affects cardiorespiratory endurance, airway muscle function, and sleep quality, while also exploring the mechanisms behind changes in OSA severity. Participants will be randomly assigned to one of two groups: a control group receiving monthly sleep hygiene education for three months, and an intervention group participating in a comprehensive respiratory training exercise program twice weekly for three months. This program includes oropharyngeal muscle training, respiratory muscle training, aerobic exercise, and sleep hygiene education. The study uses various assessments including polysomnography, cardiopulmonary exercise testing, sonography, tongue and jaw strength measurements, computed tomography, drug-induced sleep endoscopy, respiratory muscle strength, pulmonary function tests, and sleep quality questionnaires before and after the intervention period. During the study, participants will undergo multiple evaluations to measure changes in apnea-hypopnea index, oxygen desaturation, maximum oxygen consumption, tongue muscle thickness and stiffness, muscle strength and endurance, jaw strength, airway volume, and sleep parameters. Safety and treatment effects will be monitored through these tests and questionnaires. The total participation duration is three months, with assessments conducted at the start and end of the intervention to evaluate impact on OSA and related functions.
CONDITIONS
Brief Title
Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with obstructive sleep apnea with apnea-hypopnea index of 5 or more events per hour
- Age between 20 to 65 years old
- Body mass index between 18 and 30 kg/m2
You will not qualify if you...
- Diagnosed with central or mixed types of sleep apnea
- Neuromuscular disease
- Severe cardiovascular disease
- Active psychiatric disease
- Head or neck disease or cancer
- Structural abnormalities of the upper respiratory airway
- Previous operation or treatment over the neck
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either a comprehensive respiratory training exercise program or sleep hygiene education to improve cardiorespiratory endurance and airway muscle function.
Twice weekly visits for the respiratory training group, monthly visits for the sleep hygiene education group
Duration - Immediately after 3 months of treatment
Participants undergo assessments including polysomnography, sonography, muscle strength measurements, imaging, and questionnaires to evaluate changes after the intervention.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan, 704
Actively Recruiting
Research Team
J
Jun-Hui Ong, MS
C
Ching-Hsia Hung, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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