Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy (BLISS - BiLateral Inspire Sedated Stimulation)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Upper Airway Collapsability Measures
研究概览
简要总结
The study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 22yrs) willing and capable of providing informed consent
- •Implanted with the Inspire hypoglossal nerve stimulator
排除标准
- •• Pregnant women*
研究组 & 干预措施
Unilateral vs Bilateral HGNS
All participants will undergo both unilateral and bilateral hypoglossal nerve stimulation during a single drug-induced sleep endoscopy exam. The voltage will be adjusted [0.1 5.0 V].
干预措施: Nerve stimulation (Device)
结局指标
主要结局
Upper Airway Collapsability Measures
时间窗: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs
Pcrit - Critical Pressure, the maximum CPAP level where the airway is obstructed
Upper Airway Collapsability Measures
时间窗: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs.
PhOP - Pharangeal Opening Pressure, the minimum CPAP level needed to have an unobstructed airway
次要结局
- Difference in Voltage Requirements(During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs)