Clinical trial NCT04876482: Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
Official title: Efficacy of Oropharyngeal Myofunctional Therapeutic Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The 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. By their willingness to choose the therapeutic method, the participants who select the surgery interventions will be assign to TORS or TORS+OPR group. The matched controls as well as age-, sex-, and body mass index-matched OSA participants will be selected from the patients who are waiting for oral appliance, losing weight and using continuous positive airway pressure. Before surgery, 6 week and 18 week after surgery, the investiagters will compare the polysomnography data, questionnaires of sleep quality, drug-induced sleep endoscopy and computed tomography as primary outcomes. The investigators will also compare the tongue and jaw-opening muscle strength and biomarkers of oxidative stress, anti-oxidative stress, inflammatory cytokines and matrix metalloproteinases 9 as secondary outcomes. The OPR would begin at 6 week after surgery, and participants will undergo three months of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, participants will be interviewed one time per week for adjusting the treatment intensity.

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.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: through study completion, an average of 6 months
measure: Computer Tomography (CT)_Volume
timeFrame: through study completion, an average of 6 months
measure: Computer Tomography (CT)_minimal Area
timeFrame: through study completion, an average of 6 months
measure: Computer Tomography (CT)_AP Distance
timeFrame: through study completion, an average of 6 months
measure: Computer Tomography (CT)_Lateral Distance
timeFrame: through study completion, an average of 6 months
measure: Drug-induced Sleep Endoscopy (DISE)
timeFrame: through study completion, an average of 6 months
measure: Jaw Opening Muscle Strength
timeFrame: through study completion, an average of 6 months
measure: Tongue Protrusion Muscle Strength
timeFrame: through study completion, an average of 6 months
measure: Tongue Elevation Muscle Strength
timeFrame: through study completion, an average of 6 months
measure: Tongue Depression Muscle Strength
timeFrame: through study completion, an average of 6 months
measure: Tongue Lateralization Muscle Strength
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
state: Please Select
Study officials:
References: