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CompletedNCT04768621MediTAAFUpdated Sep 21, 2023

Health Consequences of Wintering in the French Southern and Antarctic Territories

An interventional study of Questionary in Environmental Exposure, Winter Depression and Endocrine System Diseases, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in Réunion. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
232
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Environmental Exposure
  • Winter Depression
  • Endocrine System Diseases
  • Sleep Disorder
  • Immunologic Activity Alteration
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 232 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 137 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Persons under guardianship or guardianship, deceased persons, persons refusing to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    Winter residents of Southern and Antartic French Lands,

    people exposed to stressors over long periods including winter

    Other: Questionary

  • 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

Interventions

  • OtherQuestionary

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: between 4 years and 9 years after polar exposure

07

Study locations

1 site
  • CHU de la Réunion
    Saint-Denis, 97400, Réunion
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04768621
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible party
Sponsor
First posted
Feb 24, 2021
Start date
Apr 20, 2021
Primary completion
Jun 19, 2021
Completion
Jun 19, 2021
Last update
Sep 21, 2023

Study contacts

Nicolas BOUSCAREN
principal investigator · CIC 1410

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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