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

This study is currently recruiting participants.
Verified March 2013 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01801592
First received: February 18, 2013
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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


Condition
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 ] [ Designated as safety issue: No ]
    Recording of sleep with the RESMED (Apnealink) system


Estimated Enrollment: 160
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

men or women over 18 years old with an Intermitent claudication.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801592

Contacts
Contact: Guillaume Mahé, MD, Ph.D 33-(0)-2-41-35-36-10 maheguillaume@yahoo.fr

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

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01801592     History of Changes
Other Study ID Numbers: 2012-A01124-39
Study First Received: February 18, 2013
Last Updated: March 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
OBSTRUCTIVE SLEEP APNOEA
INTERMITTENT CLAUDICATION
Respiratory disease
Peripheral artery disease

Additional relevant MeSH terms:
Intermittent Claudication
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014