Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-31 @ 1:59 AM
Study NCT ID:
NCT05078632
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish eye tracking standards for the test', 'timeFrame': 'during hospitalization in intensive care', 'description': 'fixation time measurement in the defined area of interest'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eye tracking', 'critical care', 'comprehension'], 'conditions': ['Critical Care']}, 'descriptionModule': {'briefSummary': 'Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.', 'detailedDescription': 'Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers and patient hospitalized in intensive care unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation\n\nExclusion Criteria:\n\n* neurovisual disorders'}, 'identificationModule': {'nctId': 'NCT05078632', 'acronym': 'MEXICO', 'briefTitle': 'Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients', 'orgStudyIdInfo': {'id': 'DR190027-MEXICO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'healthy volunteers', 'interventionNames': ['Other: Montreal-Toulouse Test adapted in eye tracking']}, {'label': 'intensive care patient', 'description': 'patient hospitalized in intensive care unit', 'interventionNames': ['Other: Montreal-Toulouse Test adapted in eye tracking']}], 'interventions': [{'name': 'Montreal-Toulouse Test adapted in eye tracking', 'type': 'OTHER', 'description': 'participant pass an eye tracking test to evaluate comprehension', 'armGroupLabels': ['Healthy volunteers', 'intensive care patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Laetitia BODET-CONTENTIN, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of TOURS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}