CompletedNot Applicable

Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

Taiwan81 participantsStarted 2020-01-01

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Apnea Hypopnea Index (AHI)

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_Volume

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_minimal Area

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_AP Distance

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_Lateral Distance

Timeframe: through study completion, an average of 6 months

Drug-induced Sleep Endoscopy (DISE)

Timeframe: through study completion, an average of 6 months

Jaw Opening Muscle Strength

Timeframe: through study completion, an average of 6 months

Tongue Protrusion Muscle Strength

Timeframe: through study completion, an average of 6 months

Trial details

NCT IDNCT04876482

SponsorNational Cheng-Kung University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2023-03-22

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials

Plain-language summary

Who can participate

Age range20 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Apnea Hypopnea Index (AHI)

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_Volume

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_minimal Area

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_AP Distance

Timeframe: through study completion, an average of 6 months

Computer Tomography (CT)_Lateral Distance

Timeframe: through study completion, an average of 6 months

Drug-induced Sleep Endoscopy (DISE)

Timeframe: through study completion, an average of 6 months

Jaw Opening Muscle Strength

Timeframe: through study completion, an average of 6 months

Tongue Protrusion Muscle Strength

Timeframe: through study completion, an average of 6 months