Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tongue base reduction surgery
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
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.
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low muscle strength
Normal groups
Arm 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%
The participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were greater than 5%
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05133011
First Posted
November 14, 2021
Last Updated
March 21, 2023
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05133011
Brief Title
Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low muscle strength
Arm Type
Experimental
Arm 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%
Arm Title
Normal groups
Arm Type
Experimental
Arm 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%
Intervention Type
Procedure
Intervention Name(s)
Tongue base reduction surgery
Intervention Description
Tongue base reduction surgery which remove the extra soft tissue of the base of the tongue and soft palate in this study
Primary Outcome Measure Information:
Title
Change from Baseline Apnea and Hypopnea index (AHI) at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Volume from hard palate to the base of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Cross section area on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Anterior to posterior distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Lateral distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Drug-induced sleep endoscopy (DISE) at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Muscle Strength of Jaw at post op 6 weeks and 18 weeks
Description
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.
Time Frame
through study completion, an average of 18 weeks
Title
Change from Baseline Muscle strength of tongue at post op 6 weeks and 18 weeks
Description
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Time Frame
through study completion, an average of 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hsia Hung, PhD
Organizational Affiliation
Department of physical therapy, National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
State/Province
Please Select
ZIP/Postal Code
412
Country
Taiwan
12. IPD Sharing Statement
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Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery
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