Evaluating the effects of surgery and rehabilitation on sleep apnea patients
The Efficacy and Maintain Effect of Oropharyngeal Rehabilitation on Obstructive Sleep Apnea Patients After Palatal Surgery
This study is testing if combining palatal surgery with tongue muscle exercises can help people with sleep apnea breathe better and improve their sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Cheng Kung University Academic / other |
| Locations | 1 site (Tainan) |
| Trial ID | NCT06115018 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of palatal surgery combined with oropharyngeal rehabilitation (OPR) in improving the severity of obstructive sleep apnea (OSA), tongue muscle strength, and upper airway space. Participants will be divided into three groups: one receiving both palatal surgery and OPR, one receiving only palatal surgery, and one receiving only OPR. The study will involve three 30-minute OPR sessions per day, performed 3-5 days a week for three months. The trial will also utilize innovative technology to monitor and provide feedback on participants' rehabilitation progress.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with mild to severe obstructive sleep apnea.
Not a fit: Patients with chronic rhinosinusitis, adenoidal hypertrophy, morbid obesity, or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of obstructive sleep apnea and enhance patients' quality of life.
How similar studies have performed: While previous studies have shown improvements with palatal surgery and OPR separately, this combined approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * mild to severe obstructive sleep apnea patients Exclusion Criteria: * Chronic rhinosinusitis with nasal polyps * Adenoidal hypertrophy * Bilateral tonsile hypertrophy * Morbid Obesity * Drug or alcohol abuse in one year * Pregnancy * Severe lung disease * Heart disease with high risk of exercise * Neuromuscular disease that can't follow the exercise program * Central or mixed sleep apnea
Where this trial is running
Tainan
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yi-Ju Lai, PhD — National Cheng Kung University
- Study coordinator: Yi-Ju Lai, PhD
- Email: 11208035@gs.ncku.edu.tw
- Phone: +886-6-2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.