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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Réunion
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Winter residents of Southern and Antartic French Lands,
people exposed to stressors over long periods including winter
Other: Questionary
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
Other: Questionary
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

  • Sociodemographic data
  • Psychological and psychiatric evaluation: Psychiatric disorder according to the College of Psychiatry Teacher; Assessment of coping strategy according to the Ways of Coping Checklist, a psychometric assessment tool recognized in the social science
  • Subjective perception of the state of health
  • Sleep disorder according to the definition of the College of Teacher of Neurology
  • Immunological state through the exploration of allergy according to College of Pulmonology Teacher, autoimmune disease according to the French College of Rhumatology Teacher (COFER), and infection by using the classification of infectious disease as presented in the Inserm epidemiological report
  • Endocrine pathology: dysthyroidism, vitamin D deficiency assessed by its complication as described by COFER
  • other pathologies presented in International Classification Disease
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de la Réunion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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