Clinical trial NCT05133011: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline Apnea and Hypopnea index (AHI) at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Volume from hard palate to the base of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Cross section area on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Anterior to posterior distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Lateral distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Drug-induced sleep endoscopy (DISE) at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Muscle Strength of Jaw at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
measure: Change from Baseline Muscle strength of tongue at post op 6 weeks and 18 weeks
timeFrame: through study completion, an average of 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
state: Please Select
Study officials:
affiliation: Department of physical therapy, National Cheng Kung University
name: Ching-Hsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: