Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT06144658
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VR-MARS Virtual Reality, Medical Assistance and Rescue for Space
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical validation of the headset in microgravity', 'timeFrame': '1 day', 'description': 'The participant had to report to the invistigators whether the headset functioned under microgravity. Images superimposed on the real environment had to be correctly placed and stable in zero-G'}, {'measure': 'Usability test HARUS / Form', 'timeFrame': '1 day', 'description': 'The HARUS (Handheld Augmented Reality Usability Scale) is a questionnaire measuring manipulability -- the ease of handling the HAR system, and comprehensibility -- the ease of understanding the information presented by augmented reality.'}, {'measure': 'NASA-TLX cognitive test', 'timeFrame': '1 day', 'description': "The NASA TLX is a subjective, multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance (task loading)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Instructional Virtual Realities', 'Weightlessness Simulation', 'Space Simulation', 'Patient Simulation', 'High Fidelity Simulation Training']}, 'descriptionModule': {'briefSummary': 'VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in microgravity the functionnality of an augmented reality headset in which a medical assistance is displayed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy male or female volunteers.\n\n* Aged between 18 and 66.\n* Not currently pregnant.\n* Affiliated to a social security system or, for non-Europeans, holders of a European Health Insurance Card (EHIC).\n* Have signed written consent for the study.\n* Have passed a standard JAR FCL3 Class 2 (Private Pilot Aptitude) medical examination less than 1 year old.\n\nExclusion Criteria:\n\nOn the day of the flight, before the volunteer boards the plane:\n\n* Flu, digestive symptoms (nausea, vomiting), fever.\n* Pregnancy: a urine pregnancy test will be performed on the morning of the flight before boarding.\n* Altered mental state (flight anxiety, phobia).\n* Failure to attend the safety briefing.\n\nDuring the flight :\n\n* Non-compliance with basic safety instructions.\n* Flight-related side effects: fatigue, motion sickness.'}, 'identificationModule': {'nctId': 'NCT06144658', 'acronym': 'VR-MARS', 'briefTitle': 'VR-MARS Virtual Reality, Medical Assistance and Rescue for Space', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier de Bretagne Sud'}, 'officialTitle': 'VR-MARS Virtual Reality, Medical Assistance and Rescue for Space', 'orgStudyIdInfo': {'id': 'ID RCB 2019- A03007- 50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmented Reality Headset Usability', 'description': 'In this arm, participants tested the functionality and usability of the headset (a Microsoft Hololens 2 or a Varjor XR3)', 'interventionNames': ['Device: Augmented Reality Headset / Hololens 2 or Varjo XR3']}], 'interventions': [{'name': 'Augmented Reality Headset / Hololens 2 or Varjo XR3', 'type': 'DEVICE', 'description': 'Augmented Reality Headset', 'armGroupLabels': ['Augmented Reality Headset Usability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Groupe Hospitalier de Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'accessCriteria': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier de Bretagne Sud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Dr Seamus Thierry', 'investigatorAffiliation': 'Groupe Hospitalier de Bretagne Sud'}}}}