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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Procedure: Tongue base reduction surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Please Select
    • Tainan, Please Select, Taiwan, 412
      • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%	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
Experimental: 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%	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Apnea and Hypopnea index (AHI) at post op 6 weeks and 18 weeks	Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI.	through study completion, an average of 18 weeks
Change from Baseline Volume from hard palate to the base of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks	All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured.	through study completion, an average of 18 weeks
Change from Baseline Cross section area on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks	All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured.	through study completion, an average of 18 weeks
Change from Baseline Anterior to posterior distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks	All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.	through study completion, an average of 18 weeks
Change from Baseline Lateral distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks	All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.	through study completion, an average of 18 weeks
Change from Baseline Drug-induced sleep endoscopy (DISE) at post op 6 weeks and 18 weeks	DISE was carried out by an experienced ENT surgeon in a semi-dark and quiet operating room with the patient supine lying on a hospital bed. Artificial sleep was induced by intravenous injection of propofol and midazolam (bolus injection of 1.5 mg) through a target-controlled infusion system (1.5 to 3.0 lg/mL), intending to the transition to unconsciousness with beginning of snoring and with the examiner evaluating decreased muscle reflexes of the eyelid. The severity of collapse in the upper airway was assessed by the surgeon.	through study completion, an average of 18 weeks
Change from Baseline Muscle Strength of Jaw at post op 6 weeks and 18 weeks	Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression.	through study completion, an average of 18 weeks
Change from Baseline Muscle strength of tongue at post op 6 weeks and 18 weeks	The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).	through study completion, an average of 18 weeks

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Ching-Hsia Hung, PhD, Department of Physical Therapy, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: B-BR-109-058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No