Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 17
- 主要终点
- AHI Change From Baseline at 3 Months
研究概览
简要总结
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.
The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.
It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate is at least 18 years old
- •Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
- •Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
- •Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
- •Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)
排除标准
- •Candidates who are pregnant
- •Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
- •Candidates with severe COPD
- •Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
- •Candidates with unstable angina
- •Candidates with history of primary pulmonary hypertension
结局指标
主要结局
AHI Change From Baseline at 3 Months
时间窗: Baseline and 3 months on therapy
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
次要结局
- Epworth Sleepiness Scale Change From Baseline at 6 Months(Baseline and 6 months on therapy)
- Related Adverse Events(Up to 2 years)
- Heart Failure Clinical Composite(6 months on therapy)
- NYHA Functional Class Improvement From Baseline to 6 Months(Baseline and 6 months on therapy)
- Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months(Baseline and 6 months on therapy)
- Six-minute Hall Walk Test Change From Baseline at 6 Months(Baseline and 6 months on therapy)