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

NCT05133011 | Completed

• 1 other identifier: B-BR-109-058
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Low muscle strength

EXPERIMENTAL

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

Normal groups

EXPERIMENTAL

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

Interventions

Tongue base reduction surgery PROCEDURE

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

Low muscle strength; Normal groups

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Please Select, 412, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ching-Hsia Hung, PhD

  Department of physical therapy, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: November 24, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 22, 2023
• Last Updated: March 23, 2023

Record last verified: 2021-11

Locations

TW (1)