Role of Obstructive Sleep Apnea in Stroke Appearance

Stroke Clinical Trial

— AVSAS  

Official title:

Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613522
• Other study ID #: CHUBX2006/10
• Secondary ID: 2007-A00382-51
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: March 4, 2015
• Start date: November 2007
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	Groupe Hospitalier Pellegrin - Place Amélie Raba Léon	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke recurrence		3 months	No
Secondary	Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance		3 months	No