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临床试验/NCT01619748
NCT01619748已完成不适用

Effects of Obstructive Sleep Apnoea and Its Treatment on Macrovascular and Microvascular Function

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Flow-mediated dilatation of the brachial artery

研究概览

简要总结

Peripheral vascular function is impaired in people with obstructive sleep apnoea who are untreated compared with age-, weight- and sex-matched healthy controls.

详细描述

Obstructive sleep apnoea (OSA) is a chronic respiratory disorder associated with endothelial dysfunction, increased sympathetic activation and increased cardiovascular risk. The standard treatment paradigm is continuous positive airway pressure (CPAP), however, patient adherence to CPAP is variable. It is unclear to what extent that poor adherence to CPAP therapy augments vascular endothelial function and reduces cardiovascular risk compared to excellent adherence. The main aim of this research is to investigate vascular endothelial function in OSA patients who are poorly-adherent to CPAP therapy. Nitric oxide (NO)-mediated, endothelium-dependent macrovascular and microvascular function (by brachial artery flow-mediated dilatation and forearm cutaneous thermal hyperaemia, respectively) and generalised microvascular function (by post-occlusion reactive hyperaemia) will be assessed in three obese OSA patient populations (high-adherence (n=20); low adherence (n=20); and, untreated (n=20)) and age-/BMI-matched OSA-free controls. We will also assess body composition, cardiovascular risk, lipid status and functional capacity. This research will evaluate treatment efficacy in patients who are poorly-adherent to CPAP treatment and could identify whether an alternative approach to their care should be explored.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Obstructive sleep apnoea diagnosed using overnight polysomnography
  • Age 18-90 years

排除标准

  • Unable to perform the tests involved in the study
  • Unable to provide written informed consent

结局指标

主要结局

Flow-mediated dilatation of the brachial artery

时间窗: Baseline only

The brachial artery dilator response to a 5-min period of forearm arterial occlusion will be measured using a vascular ultrasound scanner and a 7-MHz linear array probe.

次要结局

  • GTN-mediated dilatation of the brachial artery(Baseline only)
  • Forearm skin blood flow response to 5-min proximal-cuff arterial occlusion(Baseline only)
  • Forearm skin blood flow response to localised heating at 42 degrees C(Baseline only)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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