Environmental ExposureMediTAAFNCT04768621
Health Consequences of Wintering in the French Southern and Antarctic Territories
A study testing Questionary in people with Environmental Exposure and Winter Depression, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Winter Depression, Endocrine System Diseases
- What is being tested?
- Questionary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteReunion
- Study dates
- 20 Apr 2021to 19 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- Never have overwintered;
- Not having been refused wintering for health reasons or following psychological tests;
- Knowing how to read and write French.
Who cannot join
- Persons under guardianship or guardianship, deceased persons, persons refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Environmental Exposure, Winter Depression, Endocrine System Diseases, Sleep Disorder, Immunologic Activity Alteration
- Being tested
- Questionary
- Medical subject headings
- Seasonal Affective Disorder, Endocrine System Diseases, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaryOther
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
| Study group | Role | What they receive |
|---|---|---|
| Winter residents of Southern and Antartic French Lands, | Experimental | people exposed to stressors over long periods including winter Receives: 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 Receives: Other: Questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between 4 years and 9 years after polar exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start20 Apr 2021
- Primary completion19 Jun 2021
- Study completion19 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Questionnaire
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas BOUSCAREN, Principal investigator, CIC 1410
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768621
- Sponsor's protocol ID
- 2020/CHU/38
- Acronym
- MediTAAF
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Consequences of Wintering in the French Southern and Antarctic Territories
- ClinicalTrials.gov ID
- NCT04768621
- Acronym / sponsor ID
- MediTAAF / 2020/CHU/38
- Conditions
- Environmental Exposure, Winter Depression, Endocrine System Diseases, Sleep Disorder, Immunologic Activity Alteration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 19 Jun 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Questionnaire
| Arm | Type | Receives |
|---|---|---|
| Winter residents of Southern and Antartic French Lands, | Experimental | Other: Questionarypeople exposed to stressors over long periods including winter |
| Country people going to Southern and Antartic French Lands | Active comparator | Other: Questionarypeople going to Southern and Antarctic French Lands who benefit from milder conditions and only make short stays |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- To have taken part in one or more summer campaigns between 01jan2012 and 31dec2017;
- Never have overwintered;
Key exclusion criteria (1 listed)
- Persons under guardianship or guardianship, deceased persons, persons refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionaryQuestions 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 | Other | Country people going to Southern and Antartic French Lands, Winter residents of Southern and Antartic French Lands, |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas BOUSCAREN principal investigator
CIC 1410
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionary in people with Environmental Exposure and Winter Depression, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.