Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects
研究概览
简要总结
The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator
- •Must have symptoms of OSA prior to Inspire implantation
- •AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32
- •Age 18 or above
排除标准
- •Significant central sleep apnea
- •Presence of other sleep disorders
- •History of neurologic or neuromuscular disease
- •Historical or present substance abuse
- •Bleeding disorders
- •Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
- •Pregnancy
结局指标
主要结局
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects
时间窗: One month after surgical implantation of UAS
The hypoglossal nerve stimulator has a triode (three electrodes) that is wrapped around the nerve. Each electrode can be configured to either "Off," "Positive," or "Negative." For each electrode configuration we determined the percentage of patients with the greatest retropalatal cross-sectional area resulting from stimulation.
次要结局
未报告次要终点