Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Completed

• Conditions: Sleep Apnea

• Registration Number: NCT01801592
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-03-01
• Study Start: 2013-05-03
• Status Verified: 2016-02
• Primary Completion: 2017-10-13
• Study Completion: 2017-10-13
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of an Apnea hyponea index > 15	up to 2 months after inclusion	Recording of sleep with the RESMED (Apnealink) system

Trial Locations

Locations (1)

University hospital; 🇫🇷 Angers, France