- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911402
Motion Sickness on Astrolabe's Vessel (SICKVEST)
Evaluation and Characterization of Motion Sickness on Passengers Sailing on the Astrolabe
Study Overview
Status
Conditions
Intervention / Treatment
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.).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14033
- CAEN University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motion Sickness susceptibilty questionnaire (fMSSQ)
Time Frame: day 1 to day 10
|
Sensitivity of motion sickness
|
day 1 to day 10
|
STAY-YA questionnaire
Time Frame: day 1 to day 10
|
anxiety
|
day 1 to day 10
|
STAY-YB questionnaire
Time Frame: day 1 to day 10
|
anxiety
|
day 1 to day 10
|
Vis-Morgen Questonnaire about sleeping
Time Frame: day 1 to day 10
|
Subjective sleep scoring
|
day 1 to day 10
|
Fatigue questionnaire
Time Frame: day 1 to day 10
|
Tiredness
|
day 1 to day 10
|
Dietary intake survey
Time Frame: day 1 to day 10
|
food intake
|
day 1 to day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
type of movement from the ship using use the data from the Dynamic Positioning System on board
Time Frame: baseline and every day up to 10 days
|
boat motion
|
baseline and every day up to 10 days
|
data from individual actigraphs worn by the participants
Time Frame: baseline and every day up to 10 days
|
this will allow to quantify particpant's movements related to the ship movement
|
baseline and every day up to 10 days
|
personnality questionnaire (OCEAN)
Time Frame: baseline and every day up to 10 days
|
Personnality
|
baseline and every day up to 10 days
|
anxiety questionnaire (STAY).
Time Frame: baseline and every day up to 10 days
|
anxiety
|
baseline and every day up to 10 days
|
treatment taken (international denomination and dose)
Time Frame: baseline and every day up to 6 days
|
treatment taken by subject for motion sickness
|
baseline and every day up to 6 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: stephane Besnard, MD, CaenHU
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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