Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial

Study Overview
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Brief Summary
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Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.

Official Title
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Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial

Conditions
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Ischemic Stroke, Sleep Apnea Syndromes

Intervention / Treatment
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* Device: Nocturnal Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute ischemic stroke on brain MRI NIHSS 6-22 thrombolysis Exclusion Criteria: Previous SAS Previous stroke Auto-adaptative Servo-Ventilation Contraindication

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auto-Adaptative Servo-Ventilation<br> | Device: Nocturnal Ventilation<br>* AirCurve 10CS PaceWave (Resmed)<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct progression | Ischemic size at 7 days compared to ischemic size at admission on brain MRI | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome | modified Rankin score (mRS), from 0 (no disability) to 6 (dead) | 3 months | 
| Neurological outcome on NIHSS | National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42 | 3 months | 
| Duration of Auto-adaptative Servo-Ventilation use | mean duration per night auto-adaptative servo-ventilation was used during 7 days | 7 days | 
| SAS prevalence | assessed by respiratory polygraphy | 3 months | 
| SAS severity | assessed by apnea-hypopnea-index meseared by respiratory polygraphy, mild if AHI is 5-15/h, moderate if AHI is 15-30/h and severe if AHI is > 30/h | 3 months | 
| Central apnea index | assessed by respiratory polygraphy | 3 months | 
| Obstructive apnea index | assessed by respiratory polygraphy | 3 months | 
| Quality of life on SF-12 questionnaire | SF-12 (Short Form Survey 12) questionnaire (not a scale, result is shown as 2 numbers (physical and mental component scores) : if superior to 50, the quality of life is better to the mean quality of life in general population, if less than 50, the quality of life is worse than in the general population) | 3 months | 
| Quality of sleep on Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep) | 3 months | 
| Daytime Sleepiness | Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if > 10 | 3 months |