A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
研究概览
简要总结
The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.
详细描述
Obstructive sleep apnea (OSA) is characterised by repetitive episodes of upper airway obstruction during sleep. Systemic and airway inflammation has been recently shown to be associated with OSA and is hypothesized to contribute to the clinical manifestation and the complications of OSA patients.
Continuous positive airway pressure (CPAP) is a first-line treatment for OSA and improves diurnal and nocturnal symptoms. However, the effectiveness of CPAP in reversing airway inflammation is less compelling in comparison to systemic inflammation.
This study will assess NO in exhaled breath, inflammatory biomarkers in induced sputum and blood of OSA patients and other clinical measurements before and after 3 months of CPAP treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
- •Subjects diagnosed with OSA (apnea hypopnea index >=20/hour) by overnight polysomnography.
排除标准
- •Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
- •Treatments with corticosteroids or other immunosuppressive drugs.
结局指标
主要结局
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
时间窗: 3 months
次要结局
- Airway resistance(3 months)
- PSG measurement(AHI,etc.)(3 months)
- Quality of Life(3 months)
- Psychological status(3 months)
- Sleep quality(3 months)
- NO in exhaled breath(3 months)
研究者
Toru Oga
Associate Professor, Respiratory Care and Sleep Control Medicine, Kyoto University Graduate School of Medicine
Kyoto University, Graduate School of Medicine