Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Safety of the XII Medical HGNS System
研究概览
简要总结
The goal of this interventional study is to assess the safety and performance of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in people who have moderate to severe Obstructive Sleep Apnea (OSA).
Participation in this study involves being implanted with a Neurostimulator which provides electrical stimulation of the hypoglossal nerve (HGN). Participants will receive treatment at home during sleep, and participate in sleep studies to track and record the quality of the sleep. Participants will be monitored over the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) ≤ 32 kg/m2
- •AHI of 15-50 events/hour
- •Central + mixed apnea index ≤ 25%
- •Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
排除标准
- •Pregnancy or breast-feeding.
- •Significant upper airway anatomic abnormalities
- •Hypoglossal nerve weakness
- •Central sleep apnoea condition
- •Significant positionally-dependent OSA.
- •Complete concentric patterns of soft palate collapse on DISE
- •Inadequately treated non-OSA sleep disorder(s).
- •Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia
- •Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture
- •Participants on a GLP-1
研究组 & 干预措施
XII Medical HGNS System
Participants receiving HGNS using the XII Medical System
干预措施: XII Medical HGNS System (Device)
结局指标
主要结局
Safety of the XII Medical HGNS System
时间窗: Six months post-implantation
Assessment of serious adverse device events
次要结局
- Performance of the XII Medical HGNS System(Six months post-implantation)