StrokeAVSASNCT00613522
Role of Obstructive Sleep Apnea in Stroke Appearance
An observational study of Stroke and Obstructive Sleep Apnea, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Obstructive Sleep Apnea
- What is being tested?
- polygraphic study
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Haemorrhagic stroke
- Stroke of the brainstem
- Past medical history of ischaemic stroke
- Dementia
- Confusion
- Unable to give his informed consent
Show all 10Show fewer
- Past medical history of ischaemic stroke
- Dementia
- Confusion
- Unable to give his informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Pellegrin - Place Amélie Raba Léon
Bordeaux, 33076
About this study
Official title: Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence
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.
Read the 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
- Conditions
- Stroke, Obstructive Sleep Apnea
- Being tested
- polygraphic study
- Keywords
- Sleep apnea, Berlin, Stroke
- Medical subject headings
- Stroke, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polygraphic studyOther
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
| Study group | Role | What they receive |
|---|---|---|
| case | Fist ischaemic hemispheric stroke or TIA Receives: Other: polygraphic study | |
| control | No ischaemic hemispheric stroke or TIA Receives: Other: polygraphic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence
Measured: 3 months
Secondary outcomes (1)
Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc ORGOGOZO, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613522
- Sponsor's protocol ID
- CHUBX2006/10
- Other IDs
- 2007-A00382-51
- Acronym
- AVSAS
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2008
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence
- ClinicalTrials.gov ID
- NCT00613522
- Acronym / sponsor ID
- AVSAS / CHUBX2006/10
- Conditions
- Stroke, Obstructive Sleep Apnea
- Keywords
- Sleep apnea, Berlin, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: polygraphic studyFist ischaemic hemispheric stroke or TIA |
| control | – | Other: polygraphic studyNo ischaemic hemispheric stroke or TIA |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Fist ischaemic hemispheric stroke or TIA
- Age: 50 to 90
- French native speaker
- Able to answer the questions
- Age: 50 to 90
Key exclusion criteria (10 listed)
- Haemorrhagic stroke
- Stroke of the brainstem
- Past medical history of ischaemic stroke
- Dementia
- Confusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polygraphic studyBerlin 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 | Other | case, control |
Primary outcome
Stroke recurrence
Time frame: 3 months
1 secondary outcome
Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc ORGOGOZO, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Obstructive Sleep Apnea, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.