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临床试验/NCT01801592
NCT01801592已完成不适用

Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年5月3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
140
试验地点
1
主要终点
Prevalence of an Apnea hyponea index > 15

研究概览

简要总结

The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

详细描述

In patients with peripheral artery disease (PAD), exercise induced limb ischemia (claudication) which limits walking capacity. Symptoms are due to pain at hip and/or buttock. Couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. The rate of associated respiratory pathology to patients with lower extremity artery disease (LEAD) is around 15%. The intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. The exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. Tests which are performed to diagnose an intermittent claudication are the Ankle to Brachial Systolic pressure Index (ABI), the echo-Doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpO2).

Thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with PAD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Register to the social health insurance
  • Referred for a walk test because of claudication
  • Maximal walking ditance < 750m
  • Older than 18 years old
  • Able to understand the protocol of the study

排除标准

  • Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion
  • Severe reparatory disease already known
  • Parkinson disease, hémiplégia ou paraplégia
  • Does not want to participate to the protocol
  • Pregnant women
  • Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
  • Being in a period of exclusion from another biomedical study

结局指标

主要结局

Prevalence of an Apnea hyponea index > 15

时间窗: up to 2 months after inclusion

Recording of sleep with the RESMED (Apnealink) system

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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