NCT02911402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 15, 2022

Status Verified

January 1, 2022

Enrollment Period

3.2 years

First QC Date

September 20, 2016

Last Update Submit

January 31, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Motion Sickness susceptibilty questionnaire (fMSSQ)

    Sensitivity of motion sickness

    day 1 to day 10

  • STAY-YA questionnaire

    anxiety

    day 1 to day 10

  • STAY-YB questionnaire

    anxiety

    day 1 to day 10

  • Vis-Morgen Questonnaire about sleeping

    Subjective sleep scoring

    day 1 to day 10

  • Fatigue questionnaire

    Tiredness

    day 1 to day 10

  • Dietary intake survey

    food intake

    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

    baseline and every day up to 10 days

  • data from individual actigraphs worn by the participants

    baseline and every day up to 10 days

  • personnality questionnaire (OCEAN)

    baseline and every day up to 10 days

  • anxiety questionnaire (STAY).

    baseline and every day up to 10 days

  • treatment taken (international denomination and dose)

    baseline and every day up to 6 days

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Astrolabe passengers

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • stephane Besnard, MD

    CaenHU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 22, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

February 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations