Role of Obstructive Sleep Apnea in Stroke Appearance

NCT00613522 | Completed

• 2 other identifiers: CHUBX2006/102007-A00382-51
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Obstructive Sleep Apnea

Keywords

Sleep apnea, Berlin, Stroke

Outcome Measures

Primary Outcomes (1)

• Stroke recurrence

  3 months

Secondary Outcomes (1)

• Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance

  3 months

Study Arms (2)

case

Fist ischaemic hemispheric stroke or TIA

Other: polygraphic study

control

No ischaemic hemispheric stroke or TIA

Other: polygraphic study

Interventions

polygraphic study 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

case; control

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Groupe Hospitalier Pellegrin - Place Amélie Raba Léon

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Stroke; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Jean-Marc ORGOGOZO, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

FR (1)