Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Sleep Apnea Clinical Trial

— WITH-SAS  

Official title:

Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801592
• Other study ID #: 2012-A01124-39
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: October 30, 2017
• Start date: May 3, 2013
• Est. completion date: October 13, 2017

Study information

• Verified date: February 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 13, 2017
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Intermittent Claudication
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	University hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of an Apnea hyponea index > 15	Recording of sleep with the RESMED (Apnealink) system	up to 2 months after inclusion