NCT04768621

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2021

Completed
Last Updated

September 21, 2023

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 17, 2021

Last Update Submit

September 20, 2023

Conditions

Outcome Measures

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

    between 4 years and 9 years after polar exposure

Study Arms (2)

Winter residents of Southern and Antartic French Lands,

EXPERIMENTAL

people exposed to stressors over long periods including winter

Other: Questionary

Country people going to Southern and Antartic French Lands

ACTIVE COMPARATOR

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

Other: Questionary

Interventions

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

Country people going to Southern and Antartic French LandsWinter residents of Southern and Antartic French Lands,

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de la Réunion

Saint-Denis, 97400, Reunion

Location

MeSH Terms

Conditions

Seasonal Affective DisorderEndocrine System DiseasesSleep Wake Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas BOUSCAREN

    CIC 1410

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Questionnaire
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 24, 2021

Study Start

April 20, 2021

Primary Completion

June 19, 2021

Study Completion

June 19, 2021

Last Updated

September 21, 2023

Record last verified: 2021-02

Locations