About this trial
Obstructive sleep apnea syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting approximately 14% of men and 5% of women aged 30-70 years.
However, precise clinical prediction tools for selecting optimal treatment strategies are lacking. This study aims to develop an automated treatment clustering system using artificial intelligence to classify patients based on etiology into (i) anatomical factors, (ii) reduced muscle responsiveness, and (iii) other non-anatomical factors. This system will analyze physiological sleep assessments, such as electromyography (EMG) and pneumotachographs, from a retrospective polysomnography (PSG) database. Cross-validation will be conducted on new OSA patients undergoing various management strategies, including surgical intervention, CPAP therapy, and oropharyngeal training (delivered face-to-face or via telerehabilitation). This system aims to enhance clinicians' ability to predict treatment success rates and improve patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
OSA patients
Aged over 20 years
Disqualifiers
BMI≧ 32
Central or mixed types of sleep apnea
A history of malignancy or infection of the head and neck region and laryngeal trauma
Craniofacial malformation
Trial design
Parallel
Treatments tested in this trial
Control Group
Other interventionsleep hygiene education
Surgical Intervention
Procedure/SurgerySurgical Intervention includes uvulopalatopharyngoplasty (UPPP) and transoral robotic surgery (TORS). UPPP involves the removal of the uvula and tonsils, while TORS consists of the removal of the uvula, tonsils, and adipose tissue at the base of the tongue.
Oropharyngeal Training (face-to-face)
Other interventionParticipants will attend face-to-face oropharyngeal training sessions with a therapist in the lab, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period.
Oropharyngeal Training (telerehabilitation)
Other interventionParticipants will attend online oropharyngeal training (telerehabilitation) sessions with a therapist, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period.
Continuous Positive Airway Pressure
DeviceParticipants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period.
Treatment groups
Trial outcomes
Primary outcomes
Apnea-hypopnea -index
The apnea-hypopnea index will be obtained from the overnight Polysomnography (PSG) study. PSG will be performed in the sleep center of National Cheng Kung University Hospital. Less than 5 events/hour indicates normal; AHI between 5-14 events/hour indicates mild Obstructive Sleep Apnea(OSA); AHI between 15-30 events/hour indicates moderate OSA; and AHI more than 30 events/hour indicates severe OSA.
Secondary outcomes
Tongue muscle strength
The maximal muscle strength of genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (kPa)
Tongue muscle endurance
The endurance of the genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (in seconds).
Pharyngeal Airway Volume
Computer Tomography (CT) will be performed. The pharyngeal airway volume will be calculated from the hard palate to the epiglottis and the data will be presented in cm\^3. The minimum score is 0 and a higher score indicates greater in pharyngeal airway volume.
Cross Section Area on the Tip of Epiglottis
Computer Tomography (CT) will be performed. Cross section area on the tip of the epiglottis was measured and the data will be presented in cm\^2. The minimum score is 0 and a higher score indicates greater in the cross-sectional area of the region.
Sponsors and contacts
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