Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Difference in peak inspiratory flow
研究概览
简要总结
In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. In this study, subjects will breathe gas mixtures of different densities and viscosities for brief periods of time in order to test those models.
详细描述
Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models.
In this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP). The investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal subjects or patients with OSA
排除标准
- •Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
- •Any medication known to influence breathing, sleep/arousal or muscle physiology
- •Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
- •Claustrophobia
- •Inability to sleep supine
- •Allergy to lidocaine or oxymetazoline hydrochloride
- •For women: Pregnancy
研究组 & 干预措施
Gas mixture administration
Subjects will breathe different gas mixtures with different densities and viscosity for brief periods in order to promote changes in peak inspiratory flow
干预措施: Administration of gas mixtures (Other)
结局指标
主要结局
Difference in peak inspiratory flow
时间窗: 10 - 15 seconds
Observed peak inspiratory flow while breathing different gas mixtures will be compared to model predicted flows. Subjects will breathe different gas mixtures for 2 consecutive breaths only. Therefore the time frame is equal to one breath before gas mixture administration and two breaths after (usually 10-15 seconds).
次要结局
未报告次要终点
研究者
David Andrew Wellman
Principal Investigator
Brigham and Women's Hospital