Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-03

Study Completion Date

2017-10-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Apnea

Keywords

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OBSTRUCTIVE SLEEP APNOEA INTERMITTENT CLAUDICATION Respiratory disease Peripheral artery disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Mahe, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital in Angers

Locations

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University hospital

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01124-39

Identifier Type: -

Identifier Source: org_study_id