Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With Positive Airway Pressure Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AHI
研究概览
简要总结
Our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. The goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with CPAP in order to investigate differences in upper airway dynamics that may occur between these two mask types.
详细描述
It is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered breathing. However, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. The objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using real-time cine magnetic resonance imaging (cMRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AHI> 30/hr
- •18-75 years of age
排除标准
- •History of claustrophobia
- •History of pacemaker, nerve stimulator, or any other metal implanted device
研究组 & 干预措施
All Subjects-Nasal and Oronasal PAP Mask
Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.
干预措施: Nasal and Oronasal PAP Mask (Device)
结局指标
主要结局
AHI
时间窗: through study completion, an average of 1 hour
The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.
次要结局
- MRI of Upper Airway With Opposite PAP Mask(Approximately 1 hour)