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NCT Number: NCT00613522

Role of Obstructive Sleep Apnea in Stroke Appearance

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.

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Key information

Conditions

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

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pellegrin - Place Amélie Raba Léon

Bordeaux, 33076, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Stroke recurrence

    Time frame: 3 months

Secondary outcomes

  1. Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence

Acronym: AVSAS

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2008
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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