Clinical trial NCT00613522: Role of Obstructive Sleep Apnea in Stroke Appearance
Official title: Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Obstructive Sleep Apnea
Keywords: Sleep apnea, Berlin, Stroke
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 289
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Stroke recurrence
timeFrame: 3 months
Secondary outcomes:
measure: Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance
timeFrame: 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - Place Amélie Raba Léon
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Marc ORGOGOZO, MD
role: PRINCIPAL_INVESTIGATOR
References: