US Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
研究概览
简要总结
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with 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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Previously diagnosed with moderate-to-severe obstructive sleep apnea.
- •Subject has failed or does not tolerate CPAP treatment.
- •Age between 21 and 70 years.
- •Body mass index (BMI) less than or equal to 37.
排除标准
- 未提供
研究组 & 干预措施
HGNS System
干预措施: HGNS Treatment (Device)
结局指标
主要结局
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
时间窗: 6 months post-implant
Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline
时间窗: 6 months post-implant
The frequency of serious adverse events.
时间窗: 6 months post-implant.
The frequency of serious adverse events.
时间窗: One month post-implant.
The frequency of serious adverse events.
时间窗: 3 months post-implant.
次要结局
未报告次要终点