Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04801069
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct progression', 'timeFrame': '7 days', 'description': 'Ischemic size at 7 days compared to ischemic size at admission on brain MRI'}], 'secondaryOutcomes': [{'measure': 'Neurological outcome', 'timeFrame': '3 months', 'description': 'modified Rankin score (mRS), from 0 (no disability) to 6 (dead)'}, {'measure': 'Neurological outcome on NIHSS', 'timeFrame': '3 months', 'description': 'National Institute of Health Stroke Scale (NIHSS), from 0 (normal neurological examination) to 42'}, {'measure': 'Duration of Auto-adaptative Servo-Ventilation use', 'timeFrame': '7 days', 'description': 'mean duration per night auto-adaptative servo-ventilation was used during 7 days'}, {'measure': 'SAS prevalence', 'timeFrame': '3 months', 'description': 'assessed by respiratory polygraphy'}, {'measure': 'SAS severity', 'timeFrame': '3 months', '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'}, {'measure': 'Central apnea index', 'timeFrame': '3 months', 'description': 'assessed by respiratory polygraphy'}, {'measure': 'Obstructive apnea index', 'timeFrame': '3 months', 'description': 'assessed by respiratory polygraphy'}, {'measure': 'Quality of life on SF-12 questionnaire', 'timeFrame': '3 months', '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)'}, {'measure': 'Quality of sleep on Pittsburgh Sleep Quality Index', 'timeFrame': '3 months', 'description': 'Pittsburgh Sleep Quality Index, from 0 (good quality of sleep) to 21 (bas quality of sleep)'}, {'measure': 'Daytime Sleepiness', 'timeFrame': '3 months', 'description': 'Epworth Sleepiness Scale, from 0 (no sleepiness) to 24 (great sleepiness), sleepiness if \\> 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke', 'Sleep Apnea Syndromes']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute ischemic stroke on brain MRI\n* NIHSS 6-22\n* thrombolysis\n\nExclusion Criteria:\n\n* Previous SAS\n* Previous stroke\n* Auto-adaptative Servo-Ventilation Contraindication'}, 'identificationModule': {'nctId': 'NCT04801069', 'acronym': 'PISTACIO', 'briefTitle': 'Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial', 'organization': {'class': 'OTHER', 'fullName': 'SOS Attaque Cérébrale'}, 'officialTitle': 'Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial', 'orgStudyIdInfo': {'id': '2020-A02878-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auto-Adaptative Servo-Ventilation', 'interventionNames': ['Device: Nocturnal Ventilation']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Nocturnal Ventilation', 'type': 'DEVICE', 'description': 'AirCurve 10CS PaceWave (Resmed)', 'armGroupLabels': ['Auto-Adaptative Servo-Ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Elena Meseguer, MD', 'role': 'CONTACT', 'email': 'elena.meseguer@aphp.fr', 'phone': '0140257490'}], 'facility': 'Meseguer', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Elena Meseguer, MD', 'role': 'CONTACT', 'email': 'elena.meseguer@aphp.fr', 'phone': '01 40 25 74 86'}], 'overallOfficials': [{'name': 'Elena Meseguer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOS Attaque Cérébrale', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}