Sea SicknessSICKVESTNCT02911402
Motion Sickness on Astrolabe's Vessel
An observational study of Sea Sickness, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sea Sickness
- What is being tested?
- sea sickness questionnaires
- How many people
- 147 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Astrolabe passengers
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Characterization of Motion Sickness on Passengers Sailing on the Astrolabe
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.
Read the 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.).
- Conditions
- Sea Sickness
- Being tested
- sea sickness questionnaires
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sea sickness questionnairesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion Sickness susceptibilty questionnaire (fMSSQ)
Sensitivity of motion sickness
Measured: day 1 to day 10
STAY-YA questionnaire
anxiety
Measured: day 1 to day 10
STAY-YB questionnaire
anxiety
Measured: day 1 to day 10
Vis-Morgen Questonnaire about sleeping
Subjective sleep scoring
Measured: day 1 to day 10
Fatigue questionnaire
Tiredness
Measured: day 1 to day 10
Dietary intake survey
food intake
Measured: day 1 to day 10
Secondary outcomes (5)
type of movement from the ship using use the data from the Dynamic Positioning System on board
boat motion
Measured: baseline and every day up to 10 days
data from individual actigraphs worn by the participants
this will allow to quantify particpant's movements related to the ship movement
Measured: baseline and every day up to 10 days
personnality questionnaire (OCEAN)
Personnality
Measured: baseline and every day up to 10 days
anxiety questionnaire (STAY).
anxiety
Measured: baseline and every day up to 10 days
treatment taken (international denomination and dose)
treatment taken by subject for motion sickness
Measured: baseline and every day up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sea SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephane Besnard, MD, Principal investigator, CaenHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911402
- Sponsor's protocol ID
- 14-153
- Acronym
- SICKVEST
- Status last verified
- Jan 2022
- First submitted
- 20 Sep 2016
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Characterization of Motion Sickness on Passengers Sailing on the Astrolabe
- ClinicalTrials.gov ID
- NCT02911402
- Acronym / sponsor ID
- SICKVEST / 14-153
- Conditions
- Sea Sickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Astrolabe passengers
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sea sickness questionnaires | Other | – |
Primary outcome
Motion Sickness susceptibilty questionnaire (fMSSQ)
Time frame: day 1 to day 10
Sensitivity of motion sickness
STAY-YA questionnaire
Time frame: day 1 to day 10
anxiety
STAY-YB questionnaire
Time frame: day 1 to day 10
anxiety
Vis-Morgen Questonnaire about sleeping
Time frame: day 1 to day 10
Subjective sleep scoring
Fatigue questionnaire
Time frame: day 1 to day 10
Tiredness
Dietary intake survey
Time frame: day 1 to day 10
food intake
5 secondary outcomes
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
data from individual actigraphs worn by the participants
Time frame: baseline and every day up to 10 days
personnality questionnaire (OCEAN)
Time frame: baseline and every day up to 10 days
anxiety questionnaire (STAY).
Time frame: baseline and every day up to 10 days
treatment taken (international denomination and dose)
Time frame: baseline and every day up to 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Sea Sickness
Not yet recruiting
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Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
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Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
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Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
stephane Besnard, MD principal investigator
CaenHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sea Sickness, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion Sickness susceptibilty questionnaire (fMSSQ) (time frame: day 1 to day 10). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.