Obstructive Sleep Apnoea in Patients With Intermittent Claudication (WITH-SAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01801592|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : November 1, 2017
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication|
|Actual Study Start Date :||May 3, 2013|
|Actual Primary Completion Date :||October 13, 2017|
|Actual Study Completion Date :||October 13, 2017|
- Prevalence of an Apnea hyponea index > 15 [ Time Frame: up to 2 months after inclusion ]Recording of sleep with the RESMED (Apnealink) system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801592
|Angers, France, 49933|
|Principal Investigator:||Guillaume Mahe, MD; PhD||University Hospital in Angers|