Clinical trial NCT02911402: Motion Sickness on Astrolabe's Vessel
Official title: Evaluation and Characterization of Motion Sickness on Passengers Sailing on the Astrolabe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sea Sickness
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Astrolabe passengers

Brief 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.

Detailed 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.).

Eligibility criteria: 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

Primary outcomes:
measure: Motion Sickness susceptibilty questionnaire (fMSSQ)
timeFrame: day 1 to day 10
measure: STAY-YA questionnaire
timeFrame: day 1 to day 10
measure: STAY-YB questionnaire
timeFrame: day 1 to day 10
measure: Vis-Morgen Questonnaire about sleeping
timeFrame: day 1 to day 10
measure: Fatigue questionnaire
timeFrame: day 1 to day 10
measure: Dietary intake survey
timeFrame: day 1 to day 10
Secondary outcomes:
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
measure: data from individual actigraphs worn by the participants
timeFrame: baseline and every day up to 10 days
measure: personnality questionnaire (OCEAN)
timeFrame: baseline and every day up to 10 days
measure: anxiety questionnaire (STAY).
timeFrame: baseline and every day up to 10 days
measure: treatment taken (international denomination and dose)
timeFrame: baseline and every day up to 6 days
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: CaenHU
name: stephane Besnard, MD
role: PRINCIPAL_INVESTIGATOR
References: