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

Primary Purpose

Ischemic Stroke, Sleep Apnea Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nocturnal Ventilation
Sponsored by
SOS Attaque Cérébrale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Meseguer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Auto-Adaptative Servo-Ventilation

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neurological outcome
modified Rankin score (mRS), from 0 (no disability) to 6 (dead)
Neurological outcome on NIHSS
National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42
Duration of Auto-adaptative Servo-Ventilation use
mean duration per night auto-adaptative servo-ventilation was used during 7 days
SAS prevalence
assessed by respiratory polygraphy
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
Central apnea index
assessed by respiratory polygraphy
Obstructive apnea index
assessed by respiratory polygraphy
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)
Quality of sleep on Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep)
Daytime Sleepiness
Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if > 10

Full Information

First Posted
March 5, 2021
Last Updated
March 16, 2021
Sponsor
SOS Attaque Cérébrale
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1. Study Identification

Unique Protocol Identification Number
NCT04801069
Brief Title
Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
Acronym
PISTACIO
Official Title
Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOS Attaque Cérébrale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Sleep Apnea Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auto-Adaptative Servo-Ventilation
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Nocturnal Ventilation
Intervention Description
AirCurve 10CS PaceWave (Resmed)
Primary Outcome Measure Information:
Title
Infarct progression
Description
Ischemic size at 7 days compared to ischemic size at admission on brain MRI
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Neurological outcome
Description
modified Rankin score (mRS), from 0 (no disability) to 6 (dead)
Time Frame
3 months
Title
Neurological outcome on NIHSS
Description
National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42
Time Frame
3 months
Title
Duration of Auto-adaptative Servo-Ventilation use
Description
mean duration per night auto-adaptative servo-ventilation was used during 7 days
Time Frame
7 days
Title
SAS prevalence
Description
assessed by respiratory polygraphy
Time Frame
3 months
Title
SAS severity
Description
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
Time Frame
3 months
Title
Central apnea index
Description
assessed by respiratory polygraphy
Time Frame
3 months
Title
Obstructive apnea index
Description
assessed by respiratory polygraphy
Time Frame
3 months
Title
Quality of life on SF-12 questionnaire
Description
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)
Time Frame
3 months
Title
Quality of sleep on Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep)
Time Frame
3 months
Title
Daytime Sleepiness
Description
Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if > 10
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute ischemic stroke on brain MRI NIHSS 6-22 thrombolysis Exclusion Criteria: Previous SAS Previous stroke Auto-adaptative Servo-Ventilation Contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Meseguer, MD
Phone
01 40 25 74 86
Email
elena.meseguer@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Meseguer, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meseguer
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Meseguer, MD
Phone
0140257490
Email
elena.meseguer@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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