NCT05133011

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

Efficacy of Force Sensing Resistor Assisted Physical Therapy Program for Obstructive Sleep Apnea With Low-responsiveness of Oropharyngeal Muscle Patients After Tongue Base Reduction Surgery：Establishment of Precision Medicine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
PROCEDURE	Tongue base reduction surgery	Tongue base reduction surgery which remove the extra soft tissue of the base of the tongue and soft palate in this study

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2023-03-22
• First posted: 2021-11-24
• Last updated: 2023-03-23

Locations

1 site across 1 country: Taiwan