Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-27 @ 12:21 AM
Study NCT ID:
NCT02911402
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motion Sickness on Astrolabe's Vessel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009041', 'term': 'Motion Sickness'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion Sickness susceptibilty questionnaire (fMSSQ)', 'timeFrame': 'day 1 to day 10', 'description': 'Sensitivity of motion sickness'}, {'measure': 'STAY-YA questionnaire', 'timeFrame': 'day 1 to day 10', 'description': 'anxiety'}, {'measure': 'STAY-YB questionnaire', 'timeFrame': 'day 1 to day 10', 'description': 'anxiety'}, {'measure': 'Vis-Morgen Questonnaire about sleeping', 'timeFrame': 'day 1 to day 10', 'description': 'Subjective sleep scoring'}, {'measure': 'Fatigue questionnaire', 'timeFrame': 'day 1 to day 10', 'description': 'Tiredness'}, {'measure': 'Dietary intake survey', 'timeFrame': 'day 1 to day 10', 'description': 'food intake'}], 'secondaryOutcomes': [{'measure': 'type of movement from the ship using use the data from the Dynamic Positioning System on board', 'timeFrame': 'baseline and every day up to 10 days', 'description': 'boat motion'}, {'measure': 'data from individual actigraphs worn by the participants', 'timeFrame': 'baseline and every day up to 10 days', 'description': "this will allow to quantify particpant's movements related to the ship movement"}, {'measure': 'personnality questionnaire (OCEAN)', 'timeFrame': 'baseline and every day up to 10 days', 'description': 'Personnality'}, {'measure': 'anxiety questionnaire (STAY).', 'timeFrame': 'baseline and every day up to 10 days', 'description': 'anxiety'}, {'measure': 'treatment taken (international denomination and dose)', 'timeFrame': 'baseline and every day up to 6 days', 'description': 'treatment taken by subject for motion sickness'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sea Sickness']}, 'descriptionModule': {'briefSummary': "Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions Astrolabe, sometimes there is a risk of very significant dehydration. A special unit specialized in the fundamental study of the vestibular system (inner ear), sensory organ at the base of visual-vestibular conflict inducing this syndrome, also provides medical support for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly present. The goal of the study is to assess the frequency of occurrence of this sea sickness syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality traits, anxiety / stress) without changing habits on board for those on board taking a antinaupathique treatment given by the ship's doctor. This study will be done in collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER specialized in extreme environments (Belgium). The ultimate goal will be to provide the best recommendations and the best treatment regimen to alleviate as best as possible the symptoms of people on board of the Astrolabe so scientists on board can perform their work.", 'detailedDescription': "Background: The objectives were to assess the prevalence, severity, medication taken and to look for predictive factors, in order to better identify characteristics of passengers at risk of motion sickness during transport scientists travelling from Hobart in Tasmania to the French polar stations in Antarctica.\n\nMethods: Two hundred and thirty-nine passengers were surveyed over 4 years with 4 round trips per year using Motion Sickness Susceptibility Questionnaire (MSSQ), Simulator Sickness Questionnaire (SSQ), state-trait anxiety test (STAI-Trait and STAI-State), and general parameters (age, gender, number of trips, jet-lag, direction of the trip), medication, calculation of the distance of each passenger's cabin to the Centre of Gravity (CoG.)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Astrolabe passengers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participant aged of 18 or older but younger than 70 who received their medical ability to travel to Terre Adélie or making a research cruise aboard the Astrolabe\n* particpant signing the informed consent.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02911402', 'acronym': 'SICKVEST', 'briefTitle': "Motion Sickness on Astrolabe's Vessel", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Evaluation and Characterization of Motion Sickness on Passengers Sailing on the Astrolabe', 'orgStudyIdInfo': {'id': '14-153'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sea sickness questionnaires', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'stephane Besnard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CaenHU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}