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Completed

NCT Number: NCT01801592

Obstructive Sleep Apnoea in Patients With Intermittent Claudication

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of an Apnea hyponea index > 15

    Time frame: up to 2 months after inclusion

    Recording of sleep with the RESMED (Apnealink) system

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Acronym: WITH-SAS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2013
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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