Sleep Disorders in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3)
研究概览
简要总结
This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >=18 years
- •written informed consent
- •IPF cohort: Documented history of IPF with definite or possible UIP pattern and signs of emphysema below 10% by HRCT (IPF diagnosis according to 2011 ATS/ERS IPF guidelines)
- •COPD cohort: Documented history of COPD Stage II Group A or B, Stage III or IV, Group C or D (GOLD 2014)
排除标准
- •Long-term oxygen therapy
- •Heart failure NYHA stages III and IV
- •Left ventricular ejection fraction ≤ 45%
- •Pregnancy and/or lactation
- •Acute and/or life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, malignant tumor requiring treatment)
- •Current drug or alcohol abuse
- •Any medical, psychological or other condition impairing the patient's ability to provide informed consent
- •IPF cohort: Acute exacerbation of IPF
- •IPF cohort: Concomitant lung/airway diseases other than IPF (signs of emphysema >10% by HRCT)
- •COPD cohort: Acute exacerbation of COPD
- •COPD cohort: Concomitant lung/airway diseases other than COPD (e.g. Asthma bronchiale)
- •Healthy cohort: Documented history of structural airway or lung disease
结局指标
主要结局
Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3)
时间窗: For individual assessment of sleep disorders: one night (between 5 and 9 hours), for overall number of patients: entire study duration (37 months)
Sleep disorders defined by the International Classfication of Sleep Disorders are diagnosed by a single sleep study (polysomnography or polygraphy), lasting between 5 and 9 hours for each individual participant. The number of patients for whom at least one sleep disorder is diagnosed, is used to calculate the prevalence of sleep disorders among each patient group.
次要结局
未报告次要终点