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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02911402
Other study ID # 14-153
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date December 2018

Study information

Verified date January 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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. Methods: 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.).


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 - particpant signing the informed consent. Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sea sickness questionnaires


Locations

Country Name City State
France Caen University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motion Sickness susceptibilty questionnaire (fMSSQ) Sensitivity of motion sickness day 1 to day 10
Primary STAY-YA questionnaire anxiety day 1 to day 10
Primary STAY-YB questionnaire anxiety day 1 to day 10
Primary Vis-Morgen Questonnaire about sleeping Subjective sleep scoring day 1 to day 10
Primary Fatigue questionnaire Tiredness day 1 to day 10
Primary Dietary intake survey food intake day 1 to day 10
Secondary type of movement from the ship using use the data from the Dynamic Positioning System on board boat motion baseline and every day up to 10 days
Secondary data from individual actigraphs worn by the participants this will allow to quantify particpant's movements related to the ship movement baseline and every day up to 10 days
Secondary personnality questionnaire (OCEAN) Personnality baseline and every day up to 10 days
Secondary anxiety questionnaire (STAY). anxiety baseline and every day up to 10 days
Secondary treatment taken (international denomination and dose) treatment taken by subject for motion sickness baseline and every day up to 6 days
See also
  Status Clinical Trial Phase
Recruiting NCT05886660 - Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance Phase 2
Completed NCT05657340 - Video Head Impulse Test and Seasickness Susceptibility N/A