Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery

National Cheng-Kung University

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Procedure: Tongue base reduction surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05133011

B-BR-109-058

Details and patient eligibility

About

Obstructive sleep apnea syndrome (OSA) is a sleep-related breathing disorder defined by repetitive episodes of apnea and hypopnea. These traits include anatomical (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during airway narrowing [a low respiratory arousal threshold], ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control [high loop gain]) components. Oropharyngeal training reduces the snoring times, Apnea-hypopnea Index (AHI) and daytime sleepiness. There is lack of good evaluating tools to distinguish different phenotypes of OSA and the efficacy of combined therapy. The purposes of our study are (1) to evaluate OSA patient by using Polysomonogrphy (PSG), force sensing resistor (FRS), Drug induce sleep endoscopy (DISE) and CT and muscle strength testing, (2) to know the exercise times by using FSR and (3) the efficacy of exercise in different groups.

Full description

Subjects who are newly diagnosed with mild to severe OSA (AHI >5/h), and the physician will explain the treatment programs to every subject. By the result of muscle strength testing, the subjects will be classified as low muscle strength and normal groups. The myofunctional therapy program will begin at 6 week after surgery, and subjects will undergo 12 weeks of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, subjects will be interviewed one time per week for adjusting the treatment intensity.

Expected results：The hypothesis of this study is the efficacy of exercise would be less in the low muscle strength OSA patient than normal.

Enrollment: 28 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of mild to severe OSA in the past year
• Agree to receive Transoral Robotic Surgery (TORS)
• Age between 20-65 years old.

Exclusion criteria

• Body Mass Index ≧ 32
• Drug abuse within one year
• Pregnant
• Severe obstructive or restrictive lung disease
• 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
• Ongoing or uncontrolled chronic diseases
• Combine central or mixed types sleep apnea syndrome
• Other non-breath related sleep disorder.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Low muscle strength

Experimental group

Description:

The participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were the last 5%

Treatment:

Procedure: Tongue base reduction surgery

Normal groups

Experimental group

Description:

The participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were greater than 5%

Treatment:

Procedure: Tongue base reduction surgery