Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea -index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA patients
- •Aged over 20 years
排除标准
- •Central or mixed types of sleep apnea
- •A history of malignancy or infection of the head and neck region and laryngeal trauma
- •Craniofacial malformation
- •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
研究组 & 干预措施
Control Group
Participants who are unwilling to undergo surgery, use a mandibular advancement device, utilize continuous positive airway pressure (CPAP) devices, or undergo oropharyngeal training. They will receive sleep hygiene education.
干预措施: Control Group (Other)
Surgical Intervention
Remove excessive soft tissue from the base of the tongue, soft palate, and/or tonsil.
干预措施: Surgical Intervention (Procedure)
Oropharyngeal Training (face-to-face)
Participants 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.
干预措施: Oropharyngeal Training (face-to-face) (Other)
Oropharyngeal Training (telerehabilitation )
Participants 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.
干预措施: Oropharyngeal Training (telerehabilitation) (Other)
Continuous Positive Airway Pressure
Participants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period.
干预措施: Continuous Positive Airway Pressure (Device)
结局指标
主要结局
Apnea-hypopnea -index
时间窗: Baseline, 12 weeks, 24 weeks post intervention
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.
次要结局
- Tongue muscle strength(Baseline, 12 weeks, 24 weeks post intervention)
- Tongue muscle endurance(Baseline, 12 weeks, 24 weeks post intervention)
- Cross Section Area on the Tip of Epiglottis(Baseline, 12 weeks, 24 weeks post intervention)
- Sleep Quality(Baseline, 12 weeks, 24 weeks post intervention)
- Pharyngeal Airway Volume(Baseline, 12 weeks, 24 weeks post intervention)
- Daytime sleepiness level(Baseline, 12 weeks, 24 weeks post intervention)
- Lateral Distance on the Tip of Epiglottis(Baseline, 12 weeks, 24 weeks post intervention)
- Anterior to Posterior Distance on the Tip of the Epiglottis(Baseline, 12 weeks, 24 weeks post intervention)
- Drug-induced Sleep Endoscopy (DISE)(Baseline, 12 weeks, 24 weeks post intervention)
- Activation of brain(Baseline, 12 weeks, 24 weeks post intervention)
- Mental State Assessment(Baseline, 12 weeks, 24 weeks post intervention)