Actively Recruiting
Efficacy of Oropharyngeal Exercises for Patients With Residual Obstructive Sleep Apnea Using Mandibular Advancement Device
Led by National Cheng-Kung University Hospital · Updated on 2024-03-21
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive Sleep Apnea (OSA) is a condition where the upper airway repeatedly blocks during sleep, causing symptoms such as snoring, interrupted breathing, daytime sleepiness, and concentration problems. This research evaluates oropharyngeal muscle training as an additional treatment for patients with residual OSA who use a Mandibular Advancement Device (MAD) but have not achieved expected symptom relief. The study aims to assess changes in muscle strength, tongue shape seen by ultrasound, severity of sleep interruptions, and related symptoms. Participants diagnosed with OSA who use MAD will be divided into two groups: one receiving 12 weeks of oropharyngeal muscle training combined with MAD, and a control group continuing MAD alone. The training involves weekly visits to adjust intensity and home exercises lasting 30 minutes, 1 to 3 times daily, 3 to 5 days per week for 12 weeks. Both groups will have assessments before and after this period. During the study, participants will undergo tests measuring tongue and jaw muscle strength and endurance, ultrasound imaging of the tongue and throat, sleep physiological tests, and sleep-related questionnaires. The primary outcome is the apnea-hypopnea index measured from baseline to 12 weeks. Secondary outcomes include changes in tongue muscle strength, jaw strength, endurance, and tongue thickness. The total study duration for each participant is 12 weeks with regular follow-up visits.
CONDITIONS
Brief Title
Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with obstructive sleep apnea (OSA)
- Aged over 20 years
- Currently using a Mandibular Advancement Device (MAD) set at least 50% of the maximum achievable amount
You will not qualify if you...
- Body Mass Index (BMI) of 35 or higher
- Pregnancy
- Severe obstructive or restrictive lung disease
- High-risk cardiovascular disease preventing exercise
- History of central or peripheral neurological disease preventing exercise
- Musculoskeletal or psychological disorders preventing exercise
- Uncontrolled or ongoing chronic illnesses
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 - 12 weeks
Participants in the intervention group undergo oropharyngeal muscle training alongside mandibular advancement device therapy, with weekly in-person visits for treatment adjustment and home-based exercises. Participants in the control group continue using the mandibular advancement device without additional exercises.
1 to 2 visits per week (in-person) plus home-based exercises 3 to 5 days per week
Trial Site Locations
Total: 1 location
1
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
Research Team
M
Man-Hui Chooi, MS
C
Ching-Hsia Hung, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here