The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Basic physiologic measurements
研究概览
简要总结
Drug-induced sleep endoscopy (DISE) is a widely used tool for assessing collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. We propose a study examining the physiologic effect of palatoglossus and genioglossus muscle stimulation during DISE.
详细描述
This is a single-arm study involving the use of a diagnostic device (muscle stimulator) that is not currently utilized in any clinical decision-making processes for OSA patients. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via the previously described inclusion and exclusion criteria. The study is not blinded. No diagnostic information collected from muscle stimulation will be used in clinical decision-making processes.
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
- •Adult patient (≥18 years old)
- •A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr.
- •Intolerant of CPAP therapy due to physical or psychosocial limitations as determined by clinical history
- •Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy
排除标准
- •Unable to consent for research due to a pre-existing neurologic condition as determined by PI
- •Unable to consent for research due to language barriers
- •A history of egg allergy as determined by history or self-reports
- •Currently pregnant as determined by patient report or pre-operative anesthesia evaluation
- •Cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation
- •History of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam
- •History of radiation treatment to the head or neck as determined by history and/or physical exam
研究组 & 干预措施
Muscle stimulation
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator.
干预措施: Grass S88 Muscle Stimulator (Device)
结局指标
主要结局
Basic physiologic measurements
时间窗: Collected during operative procedure, taking about 15 minutes.
This study involves the collection of basic physiologic measurements (airway cross-sectional diameter with and without muscle stimulation) during a single session of DISE.
次要结局
- Amount of current needed for adequate stimulation(Collected during operative procedure, taking about 15 minutes.)
研究者
David Kent
Assistant Professor, Department of Otolaryngology
Vanderbilt University Medical Center