Clinical trial NCT06512779: Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
Official title: Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Keywords: Obstructive Sleep Apnea
Treatment Clustering System
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Backgrounds:

Obstructive sleep apnea syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting about 14% of men and 5% of women aged 30-70 years. The etiology of OSA is divided into anatomical and non-anatomical factors. Anatomical factors include upper airway narrowing or collapse, while non-anatomical factors encompass reduced muscle responsiveness, low arousal threshold, and high loop gain. Anatomical issues can be managed using surgical interventions or dental appliances. Non-anatomical issues like low arousal threshold and high loop gain may require pharmacological treatment or oxygen therapy. The genioglossus (GG) muscle's activity, crucial during sleep, is insufficient in about 30% of OSA patients. Regular oropharyngeal muscle exercises can reduce OSA severity and related symptoms.

However, precise clinical prediction tools for selecting optimal treatment strategies are lacking, and research on telerehabilitation for OSA patients is insufficient. 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 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).

Methods:

The automated treatment clustering system employs artificial intelligence to classify patients into etiological groups: (i) anatomical factors like upper airway narrowing or collapse; (ii) non-anatomical factors such as reduced muscle responsiveness; and (iii) other non-anatomical factors. The classification relies on analyzing multiple physiological sleep assessments, including electromyography (EMG) and pneumotachographs, from a retrospective PSG database. The system will undergo cross-validation with novel OSA patients, who will be screened based on inclusion and exclusion criteria and provide consent.

During the cross-validation phase, the OSA patients will undergo various assessments, including polysomnography, sleep-related questionnaire, drug-induced sleep endoscopy (DISE), computed tomography (CT) scans, functional magnetic resonance imaging (fMRI), tongue muscle strength and endurance tests, and mental state evaluations. Pre- and post-treatment measurements will be conducted. CT scans and DISE will assess anatomical structures before and after treatment, while fMRI will examine brain activation status. Muscle strength and endurance tests will evaluate the responsiveness level of tongue muscle before and after intervention.

The automated treatment clustering system, utilizing machine learning, will determine the phenotype of each case based on PSG, CT, sleep endoscopy, fMRI, and tongue strength and endurance results. These results will aid clinicians in categorizing patients and predicting treatment success rates. Treatment decisions will involve collaboration between physicians and patients, considering clinical expertise and patient preferences.

Participants classified as upper airway narrowing or collapse due to anatomical factors by the phenotyping system will be recommended for surgical management. For patients with reduced muscle responsiveness, a 12-week program of oropharyngeal muscle training is recommended. This training will be administered in two modes: face-to-face sessions and telerehabilitation. Each session will last 45-60 minutes, with participants attending face-to-face sessions in the lab or online classes (telerehabilitation) 1-3 days per week. Both groups will be instructed to perform additional oropharyngeal exercises at home. Patients not fitting these groups will use CPAP therapy, the gold standard for OSA management. During the treatment period, participants from all groups will have regular follow-ups to assess potential risks. Each group is expected to include 50 cases. After six months of treatment, the apnea-hypopnea index will be collected based on polysomnography to evaluate the success rates, comparing them to the predicted value analyzed using the phenotyping system.

Eligibility criteria: Inclusion Criteria:

* OSA patients
* Aged over 20 years

Exclusion Criteria:

* 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
* Stroke
* Neuromuscular disease
* Severe cardiovascular disease
* Active psychiatric disease
* Structural abnormalities over the upper respiratory airway
* Performed any operation or treatment over the neck before
* Pregnancy

Primary outcomes:
measure: Apnea-hypopnea -index
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
Secondary outcomes:
measure: Tongue muscle strength
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Tongue muscle endurance
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Pharyngeal Airway Volume
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Cross Section Area on the Tip of Epiglottis
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Anterior to Posterior Distance on the Tip of the Epiglottis
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Lateral Distance on the Tip of Epiglottis
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Drug-induced Sleep Endoscopy (DISE)
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Sleep Quality
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Daytime sleepiness level
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Activation of brain
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
measure: Mental State Assessment
timeFrame: Baseline, 12 weeks, 24 weeks post intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Ching-Hsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: