Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy

Study Overview
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Brief Summary
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The study aims to observe the short term effect (3-month) of sleep disordered breathing (SDB) on cardiovascular parameters, heart rate variability, endothelial function and surrogate markers of atherosclerosis after acute cerebrovascular events (ACE). The long-term effect (6-24-month) of Continuous Positive Airway Pressure (CPAP) on clinical vascular outcome, cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability and endothelial function after ACE is observed over 24 months. A preventive effect of CPAP therapy on cerebro-vascular events in patients with moderate-severe obstructive SDB without sleepiness after ictus or transient ischaemic attack will be evaluated.

Detailed Description
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Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events. Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events. The SAS CARE 1 study is planned to verify whether or not sleep disordered breathing has a detrimental 3 months effect on cardiovascular functions and markers after acute cerebrovascular events. The SAS CARE 2 study is designed to address whether or not the treatment of sleep disordered breathing with CPAP reduces the combined rate of mortality, stroke, cardiovascular events (myocardial infarction/revascularisation/instable angina/ hospitalisation for heart insufficiency) over a 24 months period in patients after acute cerebrovascular events.

Official Title
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Sleep Disordered Breathing in TIA/Ischemic Stroke: Effects on Short- and Long-term Outcome and CPAP Treatment Efficacy: an Open, Observational, Clinical, Multicentre Trial With a Randomized Arm

Conditions
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TIA, Ischemic Stroke

Intervention / Treatment
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* Other: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 35 years old and < 75 years old with clinical diagnosis of TIA or ischemic stroke admitted in a Stroke Unit within 2 days from onset of symptoms or with TIA or ischemic stroke within the last 60-90 days signed Informed Consent Exclusion Criteria: with unstable clinical situation (cardio-respiratory or life-threatening medical conditions) currently on CPAP or on CPAP during the last 3 months before stroke with non-ischemic events (intracerebral/subarachnoid haemorrhage) Patients with coma/stupor with borderline obstructive SDB (AHI 10-19) with any condition that interferes with the acceptance of CPAP treatment

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP in sleepy patients with SDB<br>SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10 | Other: CPAP<br> <br> |
| No Intervention: no CPAP in non sleepy patients with SDB<br>SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10 | |
| Active Comparator: CPAP in non sleepy patients with SDB<br>SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10 | Other: CPAP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported | New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke | 24 monts after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP-Compliance measured by hours of usage | Compliance is monitored for the use of the CPAP by the pulmonary specialist at the patients' routine visits 2-3, 4-6 weeks, 3-6 months, 12 and 24 months after randomisation. The hours ofuse are registered by a chip inserted in the device. Good compliance is, if the device was used > 10 hours per day. Satisfactory compliance is defined for a use of the CPAP for at least 4 hours per night during at least 70% of the nights. Insufficient compliance is defined as < 4 hours per night or less than 70% of nights. | up to 24 months after stroke | 
| Blood pressure profile (systolic mean, diastolic mean, max, min: general, day, night) measured in mmHg for every patient by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months | Mean systolic and diastolic BP values, minimal and maximum values will be calculated for each patient for each period of time [after stroke: whole measuring period, (36 h) first night, second day, and second night after stroke; 3 months after stroke: whole period (24 h), day, night]. In addition same measurements will be made 12 months after stroke The occurrence of dippers will be registered at baseline (after stroke) and at 3 months. A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data). An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered. A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data). | up to 12 months after stroke | 
| Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months | The occurrence of dippers will be registered at baseline (after stroke) and at 3 months and 12 months after stroke. A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data). An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered. A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data). | up to 12 months after stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disordered breathing, Continuous Positive Airway Pressure, Sleep apnoea, Markers of atherosclerosis