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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04768621
Other study ID # 2020/CHU/38
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2021
Est. completion date June 19, 2021

Study information

Verified date February 2021
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date June 19, 2021
Est. primary completion date June 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Réunion CHU de la Réunion Saint-Denis

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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