Completed

WITH-SASPrevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

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What is being collected

Data Collection

Who is being recruted

Apnea+16

+ Arterial Occlusive Diseases

+ Arteriosclerosis

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2013
See protocol details

Summary

Principal SponsorUniversity Hospital, Angers
Last updated: November 1, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 3, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity Hospital, Angers
Last updated: November 1, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesNervous System DiseasesRespiratory Tract DiseasesSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsVascular DiseasesPeripheral Vascular DiseasesSleep Disorders, IntrinsicDyssomniasAtherosclerosisIntermittent ClaudicationRespiration DisordersSleep Apnea SyndromesSleep Apnea, ObstructivePeripheral Arterial Disease

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University hospital

Angers, FranceOpen University hospital in Google Maps
CompletedOne Study Center