Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in variation in the conformation of the glossopharyngeal nerve
研究概览
简要总结
Published data suggest that the glossopharyngeal nerve innervates pharyngeal musculature important for maintenance of upper airway patency. The investigators propose a study examining the anatomic variation of the glossopharyngeal nerve and the effect of electrical stimulation on muscle recruitment and upper airway patency.
详细描述
This is a single-arm physiology study. Consenting patients undergoing parapharyngeal space (PPS) surgery for tumor extirpation will undergo dissection of the glossopharyngeal nerve branches to the stylopharyngeus and pharyngeal constrictor muscles. Fine-wire electrodes will be placed on these nerve branches. For each patient, if the target nerve branches can be identified and electrodes successfully placed, they will additionally undergo drug-induced sleep endoscopy (DISE) immediately following PPS surgery.
Per routine care, an incision is made across the neck to provide surgeons access to parapharyngeal space for tumor extirpation. During this dissection, the branch(es) of the glossopharyngeal nerve innervating the stylopharyngeus (SP) and pharyngeal constrictor (PC) muscles are exposed. For this study, measurements and photos/videos of the nerve will be taken. A fine-wire electrode will be placed on either or both successfully identified nerves and stimulated to assess muscle activation and changes in upper airway patency.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adults with BMI ≥ 25 and ≤ 40 kg/m2
- •Planned resection of parapharyngeal space (PPS) mass without clinical evidence of cranial nerve function deficits based on physical examination
- •History of moderate-to-severe Obstructive Sleep Apnea (OSA) as confirmed by previous polysomnogram OR high risk for OSA based on STOP-BANG criteria (STOP-BANG score ≥ 3)
排除标准
- •Unable to consent for research due to a pre-existing neurologic condition or language barriers as determined by PI
- •History of other primary sleep-related breathing disorder (e.g., central, or complex sleep apnea).
- •Previous pharyngeal surgery excluding tonsillectomy (e.g. cleft palate repair, uvulopalatopharyngoplasty)
- •Prior history of head and/or neck chemoradiation therapy
- •Existing indwelling neurostimulation device (e.g. pacemaker; spinal, vagal, or hypoglossal nerve stimulator)
结局指标
主要结局
Change in variation in the conformation of the glossopharyngeal nerve
时间窗: Collected during a single operative procedure, taking about 15 minutes.
The natural variation in the conformation of the glossopharyngeal nerve will be measured by length, diameter, and conformation of the common trunk and its dependent branches to the Stylopharyngeus Muscle (SP) and Pharyngeal Constrictor Muscles (PC), measured in mm with a flexible ruler.
次要结局
- Change in respiratory effort(Collected during a single DISE procedure, taking about 15 minutes.)
- Change in upper airway pressure(Collected during a single DISE procedure, taking about 15 minutes.)
- Change in Airway cross-sectional diameter(Collected during a single DISE procedure, taking about 15 minutes.)
- Change in airflow(Collected during a single DISE procedure, taking about 15 minutes.)
研究者
David Kent
Associate Professor, Department of Otolaryngology-Head and Neck Surgery
Vanderbilt University Medical Center