跳至主要内容
临床试验/NCT02693925
NCT02693925已完成不适用

Sleep-related Breathing Disorders in Cardiological Outpatients From a German University Clinic - Prevalence, Classification, Diagnostic Accuracy

Wissenschaftliches Institut Bethanien e.V1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Prevalence of sleep-related breathing disorders

研究概览

简要总结

The purpose of this study is to determine the prevalence of sleep-related breathing disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of polygraphy.

Furthermore, the practicability of the underlying diagnostic process in clinical application is assessed as well as the sensitivity and specificity of polygraphy as compared to the reference standard of polysomnography. Another aim is to determine the individual cardiovascular risk profile by pulse wave analysis and risk classification according to European Society of Hypertension (ESH) and European Society of Cardiology (ESC), "ESH/ESC risk".

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

入选标准

  • Age ≥18 years
  • Present chronic cardiovascular disease (incl. but not limited to: ischemic heart disease, arterial hypertension, heart failure, atrial fibrillation)
  • Current clinically stable state (incl. patients after a cardiovascular-related, emergency hospital admission and subsequent recompensation towards the end of their hospital stay

排除标准

  • Age <18 years
  • Acute life-threatening disease (incl. but not limited to:instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association (NYHA) stage IV, myocardial infarction, exacerbated chronic obstructive pulmonary disease (COPD), Malignant disease requiring treatment)
  • Pregnancy and/or lactation
  • Any medical, psychological or other condition impairing the patient's ability to provide informed consent

结局指标

主要结局

Prevalence of sleep-related breathing disorders

时间窗: Once within two days of inclusion

Prevalence of sleep-related breathing disorders as measured by ambulatory polygraphy and defined as an respiratory disturbance index of \>=15/h

次要结局

  • Number of patients included(through study completion, an average of 21 months)
  • Number of patients with actually performed polygraphy(through study completion, an average of 21 months)
  • Number of patients with assessable polygraphy(through study completion, an average of 21 months)
  • Number of patients with actually performed polysomnography(through study completion, an average of 21 months)
  • Number of patients with assessable polysomnography(through study completion, an average of 21 months)

研究者

发起方
Wissenschaftliches Institut Bethanien e.V
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验