NCT04876482

Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

Efficacy of Oropharyngeal Myofunctional Therapeutic Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
PROCEDURE	transoral robotic surgery	transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
DEVICE	oral appliance	It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
DEVICE	using continuous positive airway pressure	The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
BEHAVIORAL	losing weights	The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
COMBINATION_PRODUCT	oropharyngeal rehabilitation	OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-05-06
• Last updated: 2024-10-21
• Results posted: 2024-10-21

Locations

1 site across 1 country: Taiwan