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Obstructive Sleep Apnoea in Patients With Intermittent Claudication

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StatusCompleted
Sponsors
University Hospital, Angers

Keywords

Abstract

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

Description

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.

Dates

Last Verified: 01/31/2016
First Submitted: 02/17/2013
Estimated Enrollment Submitted: 02/25/2013
First Posted: 02/28/2013
Last Update Submitted: 10/29/2017
Last Update Posted: 10/31/2017
Actual Study Start Date: 05/02/2013
Estimated Primary Completion Date: 10/12/2017
Estimated Study Completion Date: 10/12/2017

Condition or disease

Sleep Apnea

Phase

-

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyAll
Sampling methodProbability Sample
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Outcome

Primary Outcome Measures

1. Prevalence of an Apnea hyponea index > 15 [up to 2 months after inclusion]

Recording of sleep with the RESMED (Apnealink) system

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