NCT04638933已完成不适用
Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Exhaled breath pattern
研究概览
简要总结
Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Recently diagnosed OSA (AHI ≥20/h)
- •Patient is willing to start CPAP therapy
- •ESS > 10 points
- •18 years or above
排除标准
- •Moribund or severe disease prohibiting protocol adherence
- •Use of oxygen therapy or home ventilation
- •Physical or intellectual impairment precluding informed consent or protocol adherence
- •Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR < 15 mL/min)
- •Pregnant patients
结局指标
主要结局
Exhaled breath pattern
时间窗: twice during 1 month
Change in exhaled breath pattern in response to one month of CPAP treatment
次要结局
- Therapy feedback(twice during 1 month)
- Spirometry(twice during 1 month)
- CPAP therapy(twice during 1 month)
- Vital signs(twice during 1 month)
- OSA severity parameter(twice during 1 month)
- Sleepiness(twice during 1 month)
研究者
Malcolm Kohler
Prof. Dr. med.
University of Zurich
研究点 (1)
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