Registry of Central Sleep Apnea Patients Undergoing remedē System Implant (ROSTER)
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure. The main question[s] it aims to answer [is/are]:
What is the incidence of serious adverse events related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant.
Participants will complete 2 home sleep apnea tests and be asked about adverse events. All other data collected will be from standard of care visits.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Samantha Bruning
- 电话号码：507-226-2953
- 邮箱：samantha.bruning@zoll.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Subjects who are candidates to be implanted or have been implanted (but not yet been activated) with a de novo commercial remedē System implant and meet the entry criteria are eligible for inclusion in this study.
描述
Inclusion Criteria:
- Age 22 years or older
- Baseline sleep study (polysomnogram [PSG] or home sleep apnea test [HSAT]) within 2 years prior to implant indicating moderate to severe central sleep apnea. The sleep study needs to have hypopneas classified.
- Signed Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent
- In the opinion of the investigator, subject is willing and able to comply with the protocol.
- Not currently enrolled or planning to enroll in any clinical trial/study or registry that may conflict with protocol requirements or confound subject results in this study, unless approved by the sponsor
- In the opinion of the investigator, life expectancy exceeds one year
- Not pregnant or planning to become pregnant
- Has access to a smartphone
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence of serious adverse events (SAEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
大体时间：From implant to 12 months post implant
|
From implant to 12 months post implant
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in central sleep apnea after 12 months of therapy
大体时间：From baseline to 12 months post therapy activation
|
Changes in central apnea hypopnea index (CAHI) |
From baseline to 12 months post therapy activation
|
|
Changes in sleep apnea after 12 months of therapy
大体时间：From baseline to 12 months post therapy activation
|
Changes in apnea hypopnea index (AHI) |
From baseline to 12 months post therapy activation
|
|
Changes in daytime sleepiness after 12 months of therapy
大体时间：From baseline to 12 months post therapy activation
|
Change in Epworth Sleepiness Scale from baseline to 12 months |
From baseline to 12 months post therapy activation
|
|
Incidence of non-serious adverse events (AEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
大体时间：From implant to 12 months post implant
|
From implant to 12 months post implant
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.