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| Sponsored by: |
University Hospital, Bordeaux |
|---|---|
| Information provided by: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00613522 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke Obstructive Sleep Apnea |
Other: polygraphic study |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence |
| Estimated Enrollment: | 750 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
• Principal Objective : Investigate the association between obstructive sleep apnea diagnosed and hemispheric ischemic stroke
• Secondary Objective :
Evaluate the relation between obstructive sleep apnea and:
post-stroke tolerance to CPAP treatment.
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
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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
Inclusion criteria (patients) :
Inclusion criteria (Controls):
Exclusion criteria (patients):
Exclusion criteria (Controls):
Contacts and Locations| Contact: Igor Sibon, MD-PhD | 05-56-79-55-20 | igor.sibon@chu-bordeaux.fr |
| France | |
| Groupe Hospitalier Pellegrin - Place Amélie Raba Léon | Recruiting |
| Bordeaux, France, 33076 | |
| Sub-Investigator: Pierre PHILIP, MD-PhD | |
| Sub-Investigator: Elodie GALLIAUD, MD | |
| Principal Investigator: Jean-Marc ORGOGOZO, MD | |
| Sub-Investigator: François ROUANET, MD | |
| Sub-Investigator: P. RENOU, MD | |
| Sub-Investigator: Jean-François DARTIGUES, MD-PhD | |
| Sub-Investigator: Igor SIBON, Dr | |
| Sub-Investigator: Amaya ECHEVERIA, Dr | |
| Principal Investigator: | Jean-Marc ORGOGOZO, MD | University Hospital, Bordeaux |
More Information
| Responsible Party: | University Hospital, Bordeaux ( Jean-Pierre LEROY ) |
| Study ID Numbers: | CHUBX2006/10, 2007-A00382-51 |
| Study First Received: | January 30, 2008 |
| Last Updated: | September 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00613522 |
| Health Authority: | France: Ministry of Health |
|
Sleep apnea, Berlin, Stroke |
|
Sleep Apnea Syndromes Cerebral Infarction Apnea Sleep Apnea, Obstructive Respiration Disorders Stroke Vascular Diseases Central Nervous System Diseases Dyssomnias Sleep Disorders |
Ischemia Brain Diseases Cerebrovascular Disorders Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Brain Ischemia Signs and Symptoms, Respiratory Brain Infarction Infarction |
|
Nervous System Diseases Cardiovascular Diseases |
