We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01801592
First Posted: March 1, 2013
Last Update Posted: November 1, 2017
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.
Information provided by (Responsible Party):
University Hospital, Angers
  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
Time Perspective: Other
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


Enrollment: 140
Actual Study Start Date: May 3, 2013
Study Completion Date: October 13, 2017
Primary Completion Date: October 13, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
Information from the National Library of Medicine

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


Locations
France
University hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Guillaume Mahe, MD; PhD University Hospital in Angers
  More Information

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01801592     History of Changes
Other Study ID Numbers: 2012-A01124-39
First Submitted: February 18, 2013
First Posted: March 1, 2013
Last Update Posted: November 1, 2017
Last Verified: February 2016

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

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