Role of Obstructive Sleep Apnea in Stroke Appearance (AVSAS)

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00613522
First received: January 30, 2008
Last updated: November 6, 2013
Last verified: November 2013

January 30, 2008
November 6, 2013
September 2007
December 2013   (final data collection date for primary outcome measure)
Stroke recurrence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613522 on ClinicalTrials.gov Archive Site
Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Role of Obstructive Sleep Apnea in Stroke Appearance
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.

• 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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Stroke
  • Obstructive Sleep Apnea
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

  • case
    Fist ischaemic hemispheric stroke or TIA
    Intervention: Other: polygraphic study
  • control
    No ischaemic hemispheric stroke or TIA
    Intervention: Other: polygraphic study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
Yes
Contact: Igor Sibon, MD-PhD 05-56-79-55-20 igor.sibon@chu-bordeaux.fr
France
 
NCT00613522
CHUBX2006/10, 2007-A00382-51
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Jean-Marc ORGOGOZO, MD University Hospital, Bordeaux
University Hospital, Bordeaux
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP