Ischemic Stroke, Sleep Apnea Syndromes
Conditions
Brief summary
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.
Interventions
DEVICENocturnal Ventilation
AirCurve 10CS PaceWave (Resmed)
Sponsors
SOS Attaque Cérébrale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* acute ischemic stroke on brain MRI * NIHSS 6-22 * thrombolysis
Exclusion criteria
* Previous SAS * Previous stroke * Auto-adaptative Servo-Ventilation Contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct progression | 7 days | Ischemic size at 7 days compared to ischemic size at admission on brain MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological outcome on NIHSS | 3 months | National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42 |
| Duration of Auto-adaptative Servo-Ventilation use | 7 days | mean duration per night auto-adaptative servo-ventilation was used during 7 days |
| SAS prevalence | 3 months | assessed by respiratory polygraphy |
| SAS severity | 3 months | 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 |
| Neurological outcome | 3 months | modified Rankin score (mRS), from 0 (no disability) to 6 (dead) |
| Obstructive apnea index | 3 months | assessed by respiratory polygraphy |
| Quality of life on SF-12 questionnaire | 3 months | 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) |
| Quality of sleep on Pittsburgh Sleep Quality Index | 3 months | Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep) |
| Daytime Sleepiness | 3 months | Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if \> 10 |
| Central apnea index | 3 months | assessed by respiratory polygraphy |
Countries
France
Contacts
Primary ContactElena Meseguer, MD
Outcome results
None listed