N/A
Completed N=81
Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT04876482 ↗
Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Apnea Hypopnea Index (AHI) — 44.89; 44.65; 36.87 events per hour — p=<0.05
Summary
Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index >5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
44.89; 44.65; 36.87 | <0.05 sig |
| PRIMARY Computer Tomography (CT)_Volume |
18.39; 18.72; 16.80 | <0.05 sig |
| PRIMARY Computer Tomography (CT)_minimal Area |
3.60; 3.80; 3.54 | <0.05 sig |
| PRIMARY Computer Tomography (CT)_AP Distance |
1.71; 1.64; 1.66 | <0.05 sig |
| PRIMARY Computer Tomography (CT)_Lateral Distance |
2.92; 3.43; 3.22 | <0.05 sig |
| PRIMARY Drug-induced Sleep Endoscopy (DISE) |
0; 0; 1; 9; 6; 7 | <0.05 sig |
| PRIMARY Jaw Opening Muscle Strength |
9.14; 9.63; 9.68 | <0.05 sig |
| PRIMARY Tongue Protrusion Muscle Strength |
57.83; 56.97; 61.89 | <0.05 sig |
| PRIMARY Tongue Elevation Muscle Strength |
59.17; 57.22; 63.37 | <0.05 sig |
| PRIMARY Tongue Depression Muscle Strength |
49.94; 48.22; 58.58 | <0.05 sig |
| PRIMARY Tongue Lateralization Muscle Strength |
42.19; 41.55; 50.11 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of mild to severe OSA in the past year
- Age between 20-65 years old.
Exclusion Criteria
- A history of malignancy or infection of the head and neck region and laryngeal trauma
- Craniofacial malformation
- Stroke
- Neuromuscular disease
- Heart failure
- Coronary artery disease.
Data sourced from ClinicalTrials.gov (NCT04876482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.