NCT01796925已完成不适用
Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 18
- 主要终点
- Reduction in Oxygen Desaturation Index (ODI)
研究概览
简要总结
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
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
- •Noncompliant to CPAP
- •Willing to provide informed consent
- •Willing to comply with all follow-up visits and evaluations
排除标准
- •BMI limits
- •Central Sleep Apnea
- •Anatomic variations interfering with device placement or stability.
研究组 & 干预措施
aura6000 THN Therapy
Experimental
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
干预措施: aura6000 THN System (Device)
结局指标
主要结局
Reduction in Oxygen Desaturation Index (ODI)
时间窗: 3, 6, and 12 months post implant
Change from baseline in ODI measured through in-lab polysomnography (PSG).
Reduction in Apnea-Hypopnea Index (AHI)
时间窗: 3, 6, and 12 months post implant
Change from baseline in AHI measured through in-lab polysomnography (PSG).
Freedom from Serious Adverse Events (SAE)
时间窗: 1 and 12 months post implant
Adverse events and Serious Adverse events post-operatively
次要结局
- Improvement in ESS(3, 6, and 12 months post implant)
- Improvement in sleep fragmentation(3, 6, and 12 months post-implant)
- Improvement in SAQLI(3, 6, and 12 months post implant)
研究者
研究点 (18)
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