NCT02312479终止不适用
Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea
Nyxoah S.A.2 个研究点 分布在 2 个国家目标入组 6 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation
研究概览
简要总结
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderate to severe Obstructive Sleep Apnea
- •Have failed or have not tolerated CPAP treatment
- •Willing and capable of providing informed consent
- •Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
排除标准
- •BMI limits
- •Subjects with complete concentric collapse at the soft palate level per endoscopy
结局指标
主要结局
Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation
时间窗: 6-months post-implantation
Incidence of serious device related adverse events
时间窗: 6-months post-implantation
次要结局
未报告次要终点
研究者
研究点 (2)
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