Ischemic StrokePISTACIONCT04801069
Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
A study testing Nocturnal Ventilation in people with Ischemic Stroke and Sleep Apnea Syndromes, run by SOS Attaque Cérébrale at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Sleep Apnea Syndromes
- What is being tested?
- Nocturnal Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute ischemic stroke on brain MRI
- NIHSS 6-22
- thrombolysis
Who cannot join
- Previous SAS
- Previous stroke
- Auto-adaptative Servo-Ventilation Contraindication
Trial locations and contacts
1 site in 1 country.
France1 site
Meseguer
Paris, 75018
Elena Meseguer, MD, 0140257490, elena.meseguer@aphp.fr
About this study
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.
- Conditions
- Ischemic Stroke, Sleep Apnea Syndromes
- Being tested
- Nocturnal Ventilation
- Medical subject headings
- Ischemic Stroke, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal VentilationDevice
AirCurve 10CS PaceWave (Resmed)
| Study group | Role | What they receive |
|---|---|---|
| Auto-Adaptative Servo-Ventilation | Experimental | Not described Receives: Device: Nocturnal Ventilation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct progression
Ischemic size at 7 days compared to ischemic size at admission on brain MRI
Measured: 7 days
Secondary outcomes (10)
Neurological outcome
modified Rankin score (mRS), from 0 (no disability) to 6 (dead)
Measured: 3 months
Neurological outcome on NIHSS
National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42
Measured: 3 months
Duration of Auto-adaptative Servo-Ventilation use
mean duration per night auto-adaptative servo-ventilation was used during 7 days
Measured: 7 days
SAS prevalence
assessed by respiratory polygraphy
Measured: 3 months
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
Measured: 3 months
Central apnea index
assessed by respiratory polygraphy
Measured: 3 months
Obstructive apnea index
assessed by respiratory polygraphy
Measured: 3 months
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)
Measured: 3 months
Quality of sleep on Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep)
Measured: 3 months
Daytime Sleepiness
Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if > 10
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Mar 2021 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOS Attaque Cérébrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Meseguer, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801069
- Sponsor's protocol ID
- 2020-A02878-31
- Acronym
- PISTACIO
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
- ClinicalTrials.gov ID
- NCT04801069
- Acronym / sponsor ID
- PISTACIO / 2020-A02878-31
- Conditions
- Ischemic Stroke, Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SOS Attaque CérébraleUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-Adaptative Servo-Ventilation | Experimental | Device: Nocturnal Ventilation |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute ischemic stroke on brain MRI
- NIHSS 6-22
- thrombolysis
Key exclusion criteria (3 listed)
- Previous SAS
- Previous stroke
- Auto-adaptative Servo-Ventilation Contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocturnal VentilationAirCurve 10CS PaceWave (Resmed) | Device | Auto-Adaptative Servo-Ventilation |
Primary outcome
Infarct progression
Time frame: 7 days
Ischemic size at 7 days compared to ischemic size at admission on brain MRI
10 secondary outcomes
Neurological outcome
Time frame: 3 months
Neurological outcome on NIHSS
Time frame: 3 months
Duration of Auto-adaptative Servo-Ventilation use
Time frame: 7 days
SAS prevalence
Time frame: 3 months
SAS severity
Time frame: 3 months
Central apnea index
Time frame: 3 months
Obstructive apnea index
Time frame: 3 months
Quality of life on SF-12 questionnaire
Time frame: 3 months
Quality of sleep on Pittsburgh Sleep Quality Index
Time frame: 3 months
Daytime Sleepiness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Meseguer, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nocturnal Ventilation in people with Ischemic Stroke and Sleep Apnea Syndromes, run by SOS Attaque Cérébrale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Meseguer, MD (01 40 25 74 86, elena.meseguer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct progression (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.