Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 132
- 试验地点
- 28
- 主要终点
- Safety Analysis
研究概览
简要总结
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 80 years
- •Body mass index (BMI) ≤ 35 kg/m²
- •Previously diagnosed with Moderate to severe OSA
- •Individual has failed or does not tolerate PAP therapy
排除标准
- 未提供
结局指标
主要结局
Safety Analysis
时间窗: 12 months
Description of all adverse events
Reduction in OSA Severity
时间窗: from Baseline to 6 Months
The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction \>50% and AHI \<20) and ODI 4% (reduction \>= 25% or ODI 4% \<5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group
Long-term Reduction in OSA Severity
时间窗: 12 months
The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction \>50% and AHI \<20) and ODI 4% (reduction \>=25% or ODI 4% \<5 at 12 months compared to Baseline.
次要结局
未报告次要终点