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

NCT ID: NCT05133011

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-03-22

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low muscle strength

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

Group Type: EXPERIMENTAL

Tongue base reduction surgery

Intervention Type: PROCEDURE

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

Normal groups

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

Group Type: EXPERIMENTAL

Tongue base reduction surgery

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Hsia Hung, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of physical therapy, National Cheng Kung University

Locations

National Cheng Kung University Hospital

Tainan City, Please Select, Taiwan

Countries

Taiwan

Other Identifiers

B-BR-109-058

Identifier Type: -

Identifier Source: org_study_id