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Health Consequences of Wintering in the French Southern and Antarctic Territories (MediTAAF)

Primary Purpose

Environmental Exposure, Winter Depression, Endocrine System Diseases

Status

Completed

Phase

Not Applicable

Locations

Réunion

Study Type

Interventional

Intervention

Questionary

About this trial

This is an interventional prevention trial for Environmental Exposure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de la Réunion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Winter residents of Southern and Antartic French Lands,

Country people going to Southern and Antartic French Lands

Arm Description

people exposed to stressors over long periods including winter

people going to Southern and Antarctic French Lands who benefit from milder conditions and only make short stays

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04768621

First Posted

February 17, 2021

Last Updated

September 20, 2023

Sponsor

Centre Hospitalier Universitaire de la Réunion

1. Study Identification

Unique Protocol Identification Number

NCT04768621

Brief Title

Health Consequences of Wintering in the French Southern and Antarctic Territories

Acronym

MediTAAF

Official Title

Health Consequences of Wintering in the French Southern and Antarctic Territories

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

June 19, 2021 (Actual)

Study Completion Date

June 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Environmental Exposure, Winter Depression, Endocrine System Diseases, Sleep Disorder, Immunologic Activity Alteration

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Questionnaire

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

232 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Winter residents of Southern and Antartic French Lands,

Arm Type

Experimental

Arm Description

people exposed to stressors over long periods including winter

Arm Title

Country people going to Southern and Antartic French Lands

Arm Type

Active Comparator

Arm Description

people going to Southern and Antarctic French Lands who benefit from milder conditions and only make short stays

Intervention Type

Other

Intervention Name(s)

Questionary

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

between 4 years and 9 years after polar exposure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas BOUSCAREN

Organizational Affiliation

CIC 1410

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de la Réunion

City

Saint-Denis

ZIP/Postal Code

97400

Country

Réunion

12. IPD Sharing Statement

Learn more about this trial

Health Consequences of Wintering in the French Southern and Antarctic Territories

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