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Clinical Trials/NCT01801592
NCT01801592
Completed
Not Applicable

Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

University Hospital, Angers1 site in 1 country140 target enrollmentMay 3, 2013
ConditionsSleep Apnea

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
University Hospital, Angers
Enrollment
140
Locations
1
Primary Endpoint
Prevalence of an Apnea hyponea index > 15
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 3, 2013
End Date
October 13, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Prevalence of an Apnea hyponea index > 15

Time Frame: up to 2 months after inclusion

Recording of sleep with the RESMED (Apnealink) system

Study Sites (1)

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