Role of Obstructive Sleep Apnea in Stroke Appearance (AVSAS)

March 4, 2015 updated by: University Hospital, Bordeaux

Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence

Stroke is the third leading cause of death in industrialized countries and the first cause of handicap in adults. Several stroke risk factors were identified such as high blood pressure, diabetes mellitus, hypercholesterolemia or cardiac arrhythmias. Sleep respiratory disorders have been found to be frequent among patients with stroke. Among them obstructive sleep apnea (OSA) syndrome seems to be the most important due to its association with high blood pressure and atrial fibrillation.

Stroke can be responsible of central apneas, therefore the differential diagnosis between central apneas and pure OSA after stroke is sometimes difficult. The misidentification of OSA can explain the poor tolerance of CPAP treatment by these patients. The purpose of the present study is to investigate the association between pre-stroke OSA syndrome OSA diagnosed on specific scales and confirmed by polygraphic studies and stroke occurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

• Principal Objective : Investigate the association between obstructive sleep apnea diagnosed and hemispheric ischemic stroke

• Secondary Objective :

Evaluate the relation between obstructive sleep apnea and:

  • stroke mechanisms
  • stroke prognosis

  • post-stroke tolerance to CPAP treatment.

    • Study design :

Prospective case-control study

• Inclusion criteria :

Patients (150):

Fist ischaemic hemispheric stroke or TIA Age: 50 to 90 French native speaker Able to answer the questions

Controls (600):

Age: 50 to 90 French native speaker Able to answer the questions

• Exclusion criteria : Patients Haemorrhagic stroke Stroke of the brainstem Past medical history of ischaemic stroke Dementia Confusion Unable to give his informed consent

Controls:

Past medical history of ischaemic stroke Dementia Confusion Unable to give his informed consent

• Study plan: Cases will be recruited in the stroke unit of the Pr Orgogozo at the Bordeaux University hospital. After verification of inclusion and exclusion criteria Berlin scale will be measured. A polygraphic study will be performed to patients with a Berlin scale > 2. Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).

Controls will be recruited among sex and age matched patients hospitalized at the Bordeaux-University hospital for investigation of non-vascular disorder. After verification of inclusion and exclusion criteria Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2. Controls will be evaluated at 3 months using a phone interview

• Number of subjects : 150 cases and 600 controls

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin - Place Amélie Raba Léon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases will be recruited in the stroke unit at the Bordeaux University hospital Controls will be recruited among sex and age matched patients hospitalized at the Bordeaux-University hospital for investigation of non-vascular disorder

Description

Inclusion criteria (patients) :

  • Fist ischaemic hemispheric stroke or TIA
  • Age: 50 to 90
  • French native speaker
  • Able to answer the questions

Inclusion criteria (Controls):

  • Age: 50 to 90
  • French native speaker
  • Able to answer the questions

Exclusion criteria (patients):

  • Haemorrhagic stroke
  • Stroke of the brainstem
  • Past medical history of ischaemic stroke
  • Dementia
  • Confusion
  • Unable to give his informed consent

Exclusion criteria (Controls):

  • Past medical history of ischaemic stroke
  • Dementia
  • Confusion
  • Unable to give his informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case
Fist ischaemic hemispheric stroke or TIA
Other: polygraphic study

Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2.

Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).

Controls will be evaluated at 3 months using a phone interview
control
No ischaemic hemispheric stroke or TIA
Other: polygraphic study

Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2.

Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).

Controls will be evaluated at 3 months using a phone interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stroke recurrence
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-Marc ORGOGOZO, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2006/10
  • 2007-A00382-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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