- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561677
Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.
Consequences of Obstructive Sleep Apnea Syndrome (OSAS) on the Outcome and the Survival After Ischemic Subtentorial Stroke. Impact of the Treatment With Continuous Positive Airway Pressure (CPAP)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yves DAUVILLIERS, MD-PhD
- Email: y-dauvilliers@chu-montpellier.fr
Study Locations
-
-
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Montpellier, France, 34295
- Recruiting
- University Hospital of Montpellier
-
Contact:
- Valérie Cochen De Cock
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Brain infarction confirmed by brain imaging
- follow up possible
- Severity at admission and at one week follow up:
- NIHSS ≥ 4 or- isolated aphasia (item 9 ofNIHSS ≥ 1) or
- negligence (item 11 du NIHSS ≥ 2) or
distal motor deficit (score ≥ 1)
- Health insurance affiliation
- Inform and free consent agreement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: apnea/hypopnea index (AHI<5 : no OSAS)
|
|
No Intervention: apnea/hypopnea index (5≥AHI<15 : mild OSAS)
|
|
No Intervention: apnea/hypopnea index (15≤AHI<30 :moderate OSAS)
|
|
Active Comparator: apnea/hypopnea index ( AHI≥30 : severe OSAS treated).
Treated with CPAP
|
obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap
|
Sham Comparator: apnea/hypopnea index ( AHI≥30:severe OSAS untreated).
Treated with sham CPAP (placebo)
|
inefficient Continuous Positivie Airway pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional independence scale
Time Frame: 3 months
|
The variation of the functional independence scale is evaluated by the Barthel Index at three months after stroke in four groups of patients depending on their apnea/hypopnea.In the patients group severe OSAS treated with CPAP from day 15 after stroke compared to patients with severe OSAS treated with sham CPAPThe neurological dependency will be evaluated by the Barthel Index .This scale measures the consequences of the motor and cognitive disorders on the daily living with 10 items.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neurological impairment
Time Frame: 3 months
|
The variation of the neurological impairment (NIHSS score) at three months after stroke:
|
3 months
|
the handicap
Time Frame: 3 months
|
the handicap (via the Rankin score ), at three months after stroke: in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP |
3 months
|
blood pressure
Time Frame: 3 months
|
The continuous measure of blood pressure over 24 hours at three months after stroke: in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP |
3 months
|
the quality of life
Time Frame: 3 months
|
the quality of life (SF-36) at three months after stroke: in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP |
3 months
|
the survival
Time Frame: 3 months
|
the survival at three months after stroke: in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP |
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Signs and Symptoms, Respiratory
- Brain Ischemia
- Stroke
- Infarction
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Syndrome
- Apnea
- Brain Infarction
Other Study ID Numbers
- 8670
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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