Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pupillary Dilation during Procedure
研究概览
简要总结
The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.
详细描述
The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients undergoing cochlear implantation:
- •will be undergoing surgery for a cochlear implant
- •is over the age of 18
- •is willing to participate in the study
- •Patients undergoing vagal nerve stimulator implantation:
- •will be undergoing implantable vagal nerve stimulation
- •is over the age of 18
- •is willing to participate in the study
排除标准
- •Patients undergoing cochlear implantation:
- •is under the age of 18
- •has history of prior ear surgery, congenital ear malformation, or cochlear implantation
- •pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
- •medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:
- •One vagus nerve
- •Receiving other concurrent forms of brain stimulation
- •Heart arrhythmias or other heart abnormalities
- •Dysautonomias (abnormal functioning of the autonomic nervous system)
- •Lung diseases or disorders (shortness of breath, asthma, etc.)
- •Ulcers (gastric, duodenal, etc.)
- •Vasovagal syncope (fainting)
- •Pre-existing hoarseness
- •Patients undergoing vagal nerve stimulator implantation:
- •is under the age of 18
- •has history of prior ear surgery, congenital ear malformation, or cochlear implantation
- •pregnant or breastfeeding
- •medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:
- •One vagus nerve
- •Receiving other concurrent forms of brain stimulation
- •Heart arrhythmias or other heart abnormalities
- •Dysautonomias (abnormal functioning of the autonomic nervous system)
- •Lung diseases or disorders (shortness of breath, asthma, etc.)
- •Ulcers (gastric, duodenal, etc.)
- •Vasovagal syncope (fainting)
- •Pre-existing hoarseness
研究组 & 干预措施
Vagal Nerve Stimulation during Cochlear Implantation Surgery
Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.
干预措施: Electrical stimulator (Device)
Vagal Nerve Stimulator Implantation
Control cohort undergoing vagal nerve stimulator implantation.
结局指标
主要结局
Pupillary Dilation during Procedure
时间窗: Day 1 (During procedure - typically 1 hour in duration)
Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.
次要结局
未报告次要终点