Role of Obstructive Sleep Apnea in Stroke Appearance

NCT ID: NCT00613522

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 289 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

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

Conditions

Stroke; Obstructive Sleep Apnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

case

Fist ischaemic hemispheric stroke or TIA

polygraphic study

Intervention Type: OTHER

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

polygraphic study

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc ORGOGOZO, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Groupe Hospitalier Pellegrin - Place Amélie Raba Léon

Bordeaux, , France

Countries

France

Other Identifiers

2007-A00382-51

Identifier Type: -

Identifier Source: secondary_id

CHUBX2006/10

Identifier Type: -

Identifier Source: org_study_id