- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768621
Health Consequences of Wintering in the French Southern and Antarctic Territories (MediTAAF)
September 20, 2023 updated by: Centre Hospitalier Universitaire de la Réunion
Polar stays expose people to extreme climate, isolation and confinement.
The combination of these factors induces psychological disorders, sleep disorders, immune and endocrine disturbances, and deficiencies.
In the TAAF, (French Southern and Antarctic Lands) two types of population coexist: winter residents, exposed to these stressors over long periods, and country people, who benefit from milder conditions and only make short stays.
In this context, the investigators have decided to set up this cohort study with the objective of comparing the state of health of the winterers of the TAAF from 2012 to 2017 with that of the country people of the same period, before their stay, during and the year following their return.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will answer to a questionnaire.
This questionnaire will determinate participants health about following areas : psychological disorders, sleep disorders, immune and endocrine disturbances, and any deficiencies.
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Denis, Réunion, 97400
- CHU de la Réunion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
for the exposed group are:
- To have carried out one or more wintering in one of the districts of the TAAF, that means a stay of at least six consecutive months including winter;
- Have started their first wintering between 01jan2012 and 31dec2017;
- Know how to read and write French.
for the non-exposed group are:
- To have taken part in one or more summer campaigns between 01jan2012 and 31dec2017;
- Never have overwintered;
- Not having been refused wintering for health reasons or following psychological tests;
- Knowing how to read and write French.
Exclusion Criteria:
- Persons under guardianship or guardianship, deceased persons, persons refusing to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Winter residents of Southern and Antartic French Lands,
people exposed to stressors over long periods including winter
|
Questions about patient health after wintering in Southern and Antarctic French Lands about social and demographics items, psychologic and psychiatric items, sleep disorders, immunological disorders,and endocrinologic disorders, sociological consequences of wintering
|
Active Comparator: Country people going to Southern and Antartic French Lands
people going to Southern and Antarctic French Lands who benefit from milder conditions and only make short stays
|
Questions about patient health after wintering in Southern and Antarctic French Lands about social and demographics items, psychologic and psychiatric items, sleep disorders, immunological disorders,and endocrinologic disorders, sociological consequences of wintering
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate incidence health disorders and sociological consequences of wintering of health of winterers (exposed) of TAAF from 2012 to 2017 with that of country people (not exposed) of the same period
Time Frame: between 4 years and 9 years after polar exposure
|
Measurement tool is a questionnaire Prevalence of different pathologies will be described
|
between 4 years and 9 years after polar exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicolas BOUSCAREN, CIC 1410
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2021
Primary Completion (Actual)
June 19, 2021
Study Completion (Actual)
June 19, 2021
Study Registration Dates
First Submitted
February 17, 2021
First Submitted That Met QC Criteria
February 22, 2021
First Posted (Actual)
February 24, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/CHU/38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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