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

Not Applicable

• Conditions: Sleep Apnea Syndromes; Ischemic Stroke
• Interventions: Device: Nocturnal Ventilation

• Registration Number: NCT04801069
• Lead Sponsor: SOS Attaque Cérébrale

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-05
• Study Start: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18
• Primary Completion: 2023-03-15
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• acute ischemic stroke on brain MRI
• NIHSS 6-22
• thrombolysis

Exclusion Criteria

• Previous SAS
• Previous stroke
• Auto-adaptative Servo-Ventilation Contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auto-Adaptative Servo-Ventilation	Nocturnal Ventilation	-

Primary Outcome Measures

Name	Time	Method
Infarct progression	7 days	Ischemic size at 7 days compared to ischemic size at admission on brain MRI

Secondary Outcome Measures

Name	Time	Method
Neurological outcome	3 months	modified Rankin score (mRS), from 0 (no disability) to 6 (dead)
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
Central apnea index	3 months	assessed by respiratory polygraphy
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

Trial Locations

Locations (1)

Meseguer; 🇫🇷 Paris, France