Evaluating Changes in Middle Ear Pressure Caused by CPAP
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Tympanometry
研究概览
简要总结
This study is an investigation into the effect that CPAP has on the pressure in the middle ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of CPAP pressure delivered via a full face mask. These measurements will be used to determine optimal levels of CPAP to affect individual's middle ear pressure, particularly those with negative middle ear pressure due to Eustachian tube dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No use of CPAP within past 30 days
- •Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy
排除标准
- •Pre-existing cardiopulmonary disease that presents a risk with CPAP use
- •Inability to tolerate CPAP
- •Recent otologic surgery
研究组 & 干预措施
CPAP
All participants will be included in this arm, and CPAP will be administered using a full face mask at incrementally increasing pressures. This will occur during a single session lasting no more than one hour.
干预措施: Continuous positive airway pressure (Device)
结局指标
主要结局
Tympanometry
时间窗: 1 minute
Probes in the ear canal evaluate middle ear pressure
次要结局
- Otoscopy(1 minute)
- Subjective sensation(1 minute)
- Subjective symptom score(1 minute)
研究者
Bradley Kesser, MD
Associate professor
University of Virginia