Obstructive Sleep Apnoea in Patients With Intermittent Claudication (WITH-SAS)
The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.
|Study Design:||Observational Model: Cohort|
|Official Title:||Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication|
- Prevalence of an Apnea hyponea index > 15 [ Time Frame: up to 2 months after inclusion ] [ Designated as safety issue: No ]Recording of sleep with the RESMED (Apnealink) system
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801592
|Contact: Guillaume Mahé, MD, Ph.D||33-(0)-firstname.lastname@example.org|
|Angers, France, 49933|
|Contact: Guillaume Mahé, MD, Ph.D 33-(0)-2-41-35-36-10 email@example.com|
|Contact: Pierre Abraham, MD, Ph.D 33-(0)-2-41-35-36-10 PiAbraham@chu-angers.fr|
|Principal Investigator: Guillaume Mahé, MD, Ph.D|
|Sub-Investigator: Pierre Abraham, MD, Ph.D|
|Sub-Investigator: Frédéric Gagnadoux, MD, Ph.D|
|Sub-Investigator: Alexis Le Faucheur, Ph.D|
|Principal Investigator:||Guillaume Mahe, MD; PhD||University Hospital in Angers|