Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 11
- 主要终点
- Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
研究概览
简要总结
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents.
This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 22 years)
- •Self-report of daytime somnolence
- •Body mass index (BMI) ≤ 32
- •Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)
- •Evidence of palate and tongue base collapse on supine fiberoptic examination
- •Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (< 4 hours per night by patient report)
- •No prior surgical treatment for OSAS other than nasal surgery
- •Willing and capable of providing informed consent
排除标准
- •Another significant sleep disorder (e.g., insomnia, periodic limb movement)
- •Tonsillar hypertrophy
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Interstitial Lung Disease (ILD)
- •Cystic Fibrosis
- •Acute Repiratory Distress Syndrome (ARDS)
- •Nasal or supraglottic obstruction on fiberoptic examination
- •American Society of Anesthesiologists (ASA) class III ,IV, V
- •Latex allergy
- •Lidocaine allergy
- •Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure.
- •Major depression or non-stabilized psychiatric disorder
- •Drug or alcohol abuse
- •Previous palatal or tongue surgery
- •Stable or unstable angina
- •congestive heart failure (CHF)
- •moderate or severe valvular disease
- •transient ischemic attack (TIA)/cardiovascular accident (CVA)
- •Carotid stenosis or endarterectomy
- •Room air oxygen saturation (SpO2) < 95%
- •Pulmonary hypertension
- •Central or mixed apnea ≥ 10% of respiratory events
- •Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study
结局指标
主要结局
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
时间窗: 6 months following last treatment
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
次要结局
未报告次要终点