Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Taiwan

Study Locations