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临床试验/NCT01738009
NCT01738009已完成不适用

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
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. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.

详细描述

The mechanisms that lead to airway closure in OSA are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

The investigators will test if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).

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

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 hydroclhoride
  • For women: Pregnancy

结局指标

主要结局

Difference in peak inspiratory flow

时间窗: 3 minutes

Measured peak inspiratory flow will be compared to predicted peak inspiratory flow during flow restricted breaths. The time frame for the outcome will be the duration of induced flow limitation (3 minutes each) . Flow limitation will be induced several times during the night. Flow limited breaths will be averaged.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Andrew Wellman

Principal Investigator

Brigham and Women's Hospital

研究点 (2)

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