Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
NCT Number: NCT06512779
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea of Adult
Interventions: OTHER: Control Group|PROCEDURE: Surgical Intervention|OTHER: Oropharyngeal Training (face-to-face)|OTHER: Oropharyngeal Training (telerehabilitation)|DEVICE: Continuous Positive Airway Pressure
Sponsor: National Cheng-Kung University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-30
Completion Date: 2026-05-01
Locations: National Cheng Kung University Hospital, Tainan, 701, Taiwan

Summary:
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.

Primary Outcome Measures: 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., Baseline, 12 weeks, 24 weeks post intervention
Secondary Outcome Measures: 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), Baseline, 12 weeks, 24 weeks post intervention|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)., Baseline, 12 weeks, 24 weeks post intervention|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., Baseline, 12 weeks, 24 weeks post intervention|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., Baseline, 12 weeks, 24 weeks post intervention|Anterior to Posterior Distance on the Tip of the Epiglottis, The distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the anterior to posterior in this area., Baseline, 12 weeks, 24 weeks post intervention|Lateral Distance on the Tip of Epiglottis, The distance between the lateral distance on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the lateral wall., Baseline, 12 weeks, 24 weeks post intervention|Drug-induced Sleep Endoscopy (DISE), The level of obstruction, the degree of obstruction, and the configuration of the obstructive will be identified through the drug-induced sleep endoscopy. The degree of obstruction ranged from 0 to 2. 0: no obstruction; 1: partial obstruction; 2: complete obstruction., Baseline, 12 weeks, 24 weeks post intervention|Sleep Quality, Sleep quality will be measured using Pittsburgh Sleep Quality Index (PSQI).The total score ranges from 0 to 21 with a higher total score equal to or more than 5 indicating worse sleep quality., Baseline, 12 weeks, 24 weeks post intervention|Daytime sleepiness level, Epworth Sleepiness Score(ESS) will be used to measure the daytime sleepiness of OSA patients. The total score of ESS range from 0-24. A score greater than 10 indicates greater daytime sleepiness., Baseline, 12 weeks, 24 weeks post intervention|Activation of brain, Functional MRI (fMRI) will be conducted by psychiatrists to evaluate the activation of brain areas in a relaxed state, including the amygdala, hippocampus, insula, locus coeruleus, ventromedial prefrontal cortex, mammillary bodies, and lateral hypothalamus., Baseline, 12 weeks, 24 weeks post intervention|Mental State Assessment, Using the Hospital Anxiety and Depression Scale (HADS) to assess subjects' mood over the past week. HADS. Each subscale has a maximum score of 21, with higher scores indicating greater anxiety or depression., Baseline, 12 weeks, 24 weeks post intervention