Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.

Study Overview
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Brief Summary
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Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. The aim of the investigators study is first to evaluate the outcome and the survival of patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome and survival of patients with severe OSAS depending on the treatment of the syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is associated with worst survival and outcome and needs to be treated at the subacute phase of stroke.

Detailed Description
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Objective : The aim of our study is to evaluate the consequences of obstructive sleep apnea syndrome on the functional outcome and the survival after an ischemic stroke and to measure the impact of the treatment with continuous positive airway pressure on the outcome of patients with severe obstructive sleep apnea syndrome.Patients and methods : We will prospectively explore by polysomnography, 300 consecutive patients hospitalized for an ischemic stroke in the stroke units of university hospitals at the sub acute phase after stroke (J15±4). 1) We will compare the functional outcome, the neurological impairment, the peripheral endothelial function, the continuous blood pressure measure on 24 hours recording, the quality of life and the survival at 3, 6 and 12 months in four groups of patients depending on their apnea/hypopnea index 2) In patients with severe obstructive sleep apnea syndrome, we will explore the impact on the functional outcome, the neurological impairment, and the survival at 3, 6 et 12 months of a treatment with continuous positive airway pressure (CPAP) randomly compared to a treatment with sham CPAP (non efficacious pressure) during 3 months. Conclusion : This study should allow us to evaluate the consequences of obstructive sleep apnea syndrome on the outcome and the survival after ischemic stroke and the impact and the tolerance of the treatment with continuous positive airway pressure in patients with severe obstructive sleep apnea syndrome.

Official Title
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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)

Conditions
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Obstructive Sleep Apnea Syndrome, Brain Infarction

Intervention / Treatment
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* Device: Continuous Positive Airway pressure-RESPIRONICS
* Device: Sham Continuous Positive Airway pressure-RESPIRONICS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: apnea/hypopnea index (AHI<5 : no OSAS)<br> | |
| No Intervention: apnea/hypopnea index (5≥AHI<15 : mild OSAS)<br> | |
| No Intervention: apnea/hypopnea index (15≤AHI<30 :moderate OSAS)<br> | |
| Active Comparator: apnea/hypopnea index ( AHI≥30 : severe OSAS treated).<br>Treated with CPAP | Device: Continuous Positive Airway pressure-RESPIRONICS<br>* obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap<br>|
| Sham Comparator: apnea/hypopnea index ( AHI≥30:severe OSAS untreated).<br>Treated with sham CPAP (placebo) | Device: Sham Continuous Positive Airway pressure-RESPIRONICS<br>* inefficient Continuous Positivie Airway pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional independence scale | 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 | The variation of the neurological impairment (NIHSS 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 | 
| the handicap | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, syndrome survival, ischemic stroke, continuous positive airway pressure, handicap