Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
研究概览
简要总结
This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult (>18yrs at the time of recruitment)
- •Body mass index (BMI) ≥ 30
- •Symptoms suggestive of sleep apnea
- •Epworth Sleepiness Score (ESS) within range
- •Positive sleep study for sleep apnea
排除标准
- •Tobacco use within the last 3 months.
- •Presence of other significant comorbid heart or lung disease
- •Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
- •Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
- •Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
- •Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
- •History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
- •Night shift workers, or other subjects with significantly altered sleep-wake cycles.
- •Baseline post-bronchodilator FEV1 < 70% predicted.
- •Severe gastroesophageal reflux disease.
结局指标
主要结局
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
Endobronchial biopsies to analyze extent and type of inflammatory cell.
BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
次要结局
- Post-CPAP methacholine for bronchial hyperreactivity
- Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
- Spirometry measured at three time points: before, during, and after CPAP therapy.