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

March 16, 2021 updated by: SOS Attaque Cérébrale
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct progression
Time Frame: 7 days
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
Time Frame: 3 months
modified Rankin score (mRS), from 0 (no disability) to 6 (dead)
3 months
Neurological outcome on NIHSS
Time Frame: 3 months
National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42
3 months
Duration of Auto-adaptative Servo-Ventilation use
Time Frame: 7 days
mean duration per night auto-adaptative servo-ventilation was used during 7 days
7 days
SAS prevalence
Time Frame: 3 months
assessed by respiratory polygraphy
3 months
SAS severity
Time Frame: 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
3 months
Central apnea index
Time Frame: 3 months
assessed by respiratory polygraphy
3 months
Obstructive apnea index
Time Frame: 3 months
assessed by respiratory polygraphy
3 months
Quality of life on SF-12 questionnaire
Time Frame: 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)
3 months
Quality of sleep on Pittsburgh Sleep Quality Index
Time Frame: 3 months
Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep)
3 months
Daytime Sleepiness
Time Frame: 3 months
Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if > 10
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOS Attaque Cérébrale

Investigators

  • Principal Investigator: Elena Meseguer, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02878-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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