Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Identification and access of the target outcomes
研究概览
简要总结
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Subject must be eligible for an OSA diagnostic or surgical procedure.
- •Subject suffers with moderate to severe OSA based on history and a physical exam.
- •Subject has failed, refused or has not tolerated CPAP treatment.
- •Subject is willing and capable of providing informed consent.
- •Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
- •-Subject is willing to participate in the designated follow-up visits.
- •Subject must be in good general health.
- •Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
- •Subject must be minimum of 21 years and maximum 80 years of age.
- •Subject's Hypoglossal Nerve must be able to be visualized using ultrasound
排除标准
- •Subject has Body Mass Index above 38kg/m
- •Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
- •Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
- •Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.
研究组 & 干预措施
Hypoglossal nerve stimulation
干预措施: Hypoglossal nerve stimulation (Device)
结局指标
主要结局
Identification and access of the target outcomes
时间窗: Day 0
Consistent identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve.
Tongue protrusion outcomes
时间窗: Day 0
Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.
Characterization of electrode array outcomes
时间窗: Day 0
Spatial characterization of the orientation of the electrode array and lead body to the target stimulation location considering suitable chronic anchoring locations.
Electrode array placement and removal outcomes
时间窗: Day 0
To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.
Safety outcomes
时间窗: Day 30
To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study
次要结局
未报告次要终点