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

Ischemic Stroke Clinical Trial

— PISTACIO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04801069
• Other study ID #: 2020-A02878-31
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 15, 2023

Study information

• Verified date: March 2021
• Source: SOS Attaque Cérébrale
• Contact: Elena Meseguer, MD
• Phone: 01 40 25 74 86
• Email: elena.meseguer[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Ischemic Stroke
• Sleep Apnea Syndromes

Intervention

Device:
• Nocturnal Ventilation
AirCurve 10CS PaceWave (Resmed)

Locations

Country	Name	City	State
France	Meseguer	Paris

Sponsors (1)

Lead Sponsor	Collaborator
SOS Attaque Cérébrale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct progression	Ischemic size at 7 days compared to ischemic size at admission on brain MRI	7 days
Secondary	Neurological outcome	modified Rankin score (mRS), from 0 (no disability) to 6 (dead)	3 months
Secondary	Neurological outcome on NIHSS	National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42	3 months
Secondary	Duration of Auto-adaptative Servo-Ventilation use	mean duration per night auto-adaptative servo-ventilation was used during 7 days	7 days
Secondary	SAS prevalence	assessed by respiratory polygraphy	3 months
Secondary	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
Secondary	Central apnea index	assessed by respiratory polygraphy	3 months
Secondary	Obstructive apnea index	assessed by respiratory polygraphy	3 months
Secondary	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
Secondary	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
Secondary	Daytime Sleepiness	Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if > 10	3 months