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Obstructive Sleep Apnoea in Patients With Intermittent Claudication (WITH-SAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University Hospital, Angers
Information provided by (Responsible Party):
University Hospital, Angers Identifier:
First received: February 18, 2013
Last updated: February 11, 2016
Last verified: February 2016
The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Resource links provided by NLM:

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Prevalence of an Apnea hyponea index > 15 [ Time Frame: up to 2 months after inclusion ]
    Recording of sleep with the RESMED (Apnealink) system

Estimated Enrollment: 160
Study Start Date: February 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
men or women over 18 years old with an Intermitent claudication.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01801592

Contact: Guillaume Mahé, MD, Ph.D 33-(0)-2-41-35-36-10

University hospital Recruiting
Angers, France, 49933
Contact: Guillaume Mahé, MD, Ph.D    33-(0)-2-41-35-36-10   
Contact: Pierre Abraham, MD, Ph.D    33-(0)-2-41-35-36-10   
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         
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Guillaume Mahe, MD; PhD University Hospital in Angers
  More Information

Responsible Party: University Hospital, Angers Identifier: NCT01801592     History of Changes
Other Study ID Numbers: 2012-A01124-39
Study First Received: February 18, 2013
Last Updated: February 11, 2016

Keywords provided by University Hospital, Angers:
Respiratory disease
Peripheral artery disease

Additional relevant MeSH terms:
Intermittent Claudication
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 28, 2017