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临床试验/NCT01814462
NCT01814462已完成不适用

Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis

Wissenschaftliches Institut Bethanien e.V1 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2013年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
314
试验地点
1
主要终点
Change in pulse wave attenuation index

研究概览

简要总结

The present study aims to document and assess changes in single parameters of pulse wave analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with obstructive sleep apnea.

详细描述

Obstructive sleep apnea (OSA) is characterized by repeated occurrence of apneas or reduced inspiratory air flow due to obstructions of the upper airways (hypopneas). These recurring events are accompanied by intermittent hypoxemia and sympathetic activation, leading to hemodynamic oscillations including relevant variations of pulse wave and blood pressure. Thus, OSA is associated with cardiovascular diseases and was identified as an independent risk factor for hypertension.

Direct effects of obstructive respiratory events (obstructive apneas and hypopneas) include changes of the peripheral pulse wave. The latter can easily be measured by finger plethysmography, e.g. by using established pulse oximeters. Certain pulse wave characteristics and their reaction towards obstructive respiratory events may provide information on cardiovascular function and thereby help in individual cardiovascular risk assessment.

Recently, Grote et al. published a concept for cardiovascular risk assessment based on pulse oximetry and pulse wave analysis ("ASI" - Grote et al. 2011, CHEST). The algorithm described herein is able to differentiate between high and low risk patients according to ESH/ESC risk classification (high risk = 4 and 5, low risk 1-3). To that end, oxygen saturation as measured by pulse oximetry, reductions in pulse wave amplitude, pulse rate accelerations, pulse propagation time and cardiorespiratory coupling are taken into account to calculate a quantitative total risk.

A successful OSA therapy applying positive airway pressure (e.g. CPAP) normalizes sleep-related breathing disturbances and thus counterbalances hemodynamic oscillations. This presumably results in reduced cardiovascular risk and should be detectable by measurable changes in pulse wave. This study aims to evaluate these effects by analyzing the single pulse wave parameters, which are part of the ASI algorithm. At the same time, established risk factors as well as the objective therapy outcome will be documented from the established sleep medicine viewpoint.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • •Sleep-related breathing disorders with an apnea-hypopnea index ≥15/h and <30% central respiratory events (OSA patients)
  • •Stable optimal medication according to European Society of Cardiology guidelines (if applicable)

排除标准

  • •Prior exposure to positive airway pressure treatment
  • •Atrial fibrillation
  • •Facial anomalies or injuries inhibiting proper mask fit
  • •Pregnancy and/or lactation
  • •Acute life-threatening illness (e.g. instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association stage IV, myocardial infarction, exacerbated Chronic obstructive pulmonary disease, malignant tumor requiring treatment)
  • •Drug or alcohol abuse
  • •Intake of hypnotics/sedatives
  • •Any medical, psychological or other condition impairing the patient's ability to provide informed consent

研究组 & 干预措施

6 months CPAP

Experimental

Application of continuous positive airway pressure (CPAP) therapy as established per routine clinical treatment. Home use of therapy for a period of 6 months.

干预措施: 6 months CPAP (Device)

结局指标

主要结局

Change in pulse wave attenuation index

时间窗: 6 months

The pulse wave attenuation index represents the number of decreases of the pulse wave amplitude \>10% and \<30% compared with baseline (a moving median value of 20 samples surrounding the observed sample). This number is given as attenuations per hour. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

次要结局

  • Change in pulse rate acceleration index(6 months)
  • Change in hypoxia index(6 months)
  • Change in ASI cardiovascular risk score(6 months)
  • Change in mean pulse propagation time(6 months)
  • Change in mean respiration-related pulse oscillation(6 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)

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