Minimally Invasive Hypoglossal Nerve Stimulation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Effect of transvenous hypoglossal nerve stimulation on tongue position
研究概览
简要总结
The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that require an open surgical approach to wrap a cuff electrode around the HGN.
详细描述
The primary objective is to determine the effect of tHGNS on tongue position in the upper airway in subjects undergoing an EP, cardiac catheterization or device procedure. (Measured as changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces.) This will be an acute study lasting no more than 45 min during a standard new device implant, cardiac catheterization and/or EP procedure. The hypoglossal nerve will be stimulated from the lingual vein using various stimulation parameters. Tongue motion, upper airway opening or any side effects will be recorded. At the end of the test procedure all hardware - the catheters, lead and/or guide wire will be removed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years old
- •Subject is undergoing a standard new device implant, cardiac catheterization involving right heart catheterization and/or EP procedures
- •Subject is able and willing to give informed consent
排除标准
- •Subject is unable or unwilling to participate with study procedures
- •Subject is pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment)
- •Subject is known to be allergic to radio opaque dye
- •Subject has a body mass index (BMI) >40 kg/m2
- •Subject has had prior neck surgery that may interfere with vascular access to the lingual vein
- •Subject has had prior surgery of the oral cavity that may interfere with tongue or soft palate movement
- •Subject has a significant upper airway-related anatomic anomaly
- •Subject is enrolled in a concurrent study that may confound the results of this study.
研究组 & 干预措施
Transvenous hypoglossal nerve stimulation
Transvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure.
干预措施: Transvenous hypoglossal nerve stimulation (Procedure)
结局指标
主要结局
Effect of transvenous hypoglossal nerve stimulation on tongue position
时间窗: During study procedure
Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.
次要结局
未报告次要终点