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Study of Chronic Exposure of the Population Living on the Atlantic Coast and on the Caribbean Coast, in Martinique, During the Stranding Period and Outside the Stranding Period of Sargassum Seaweeds (SÉSAR)

U

University Hospital Center of Martinique

Status

Completed

Conditions

Obstructive Ventilatory Disorders

Treatments

Procedure: Spirometry
Procedure: FeNO (fractional exhaled nitric oxide)
Other: Interrogation
Other: Physical examination

Study type

Interventional

Funder types

Other

Identifiers

NCT05564546
22_RIPH2-04
2022-A01382-41 (Registry Identifier)

Details and patient eligibility

About

Sargassum are pelagic brown sea algae. Two species grow on the surface of the ocean and drift freely with ocean currents in the form of slicks: the pelagic Sargassum fluitans and Sargassum natans.

Since 2011, massive strandings of Sargassum seaweed in the French West Indies are to be deplored. In recent years, strandings have increased. In Martinique, sargassum stranding occurs mainly on the Atlantic coast. The duration of stranding from one year to another is variable, but the period during which the stranding is maximum is between April and October.

The accumulation of strandings causes the compaction of algae and limits access to oxygen, which leads to anaerobic degradation which quickly results in the release of various gases, in particular hydrogen sulphide (H2S).

Acute H2S poisoning is well characterized clinically according to exposure (cutaneous, respiratory, ophthalmological, digestive, neurological symptoms, etc.). On the other hand, there are very few data available on the clinical effects of prolonged, repeated exposure and most often at low doses.

Among the toxic effects for which there are still uncertainties regarding long-term exposure to H2S are lung function, measured by spirometry, and airway inflammation, appreciable by measurement of FeNO (fractional exhaled nitric oxide).

The investigators consider it relevant to focus on the clinical and biological characteristics of the population exposed to sargassum in Martinique, in the field, assuming that exposure to sargassum H2S causes pulmonary effects measurable by spirometry and by FeNO, during the stranding period and outside this period.

Enrollment

173 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult participant (age greater than or equal to 18),
  • Participant living on the Atlantic coast in Martinique, close (less than 300 meters) to sargassum seaweed stranding areas (exposed group),
  • Participant living on the Caribbean coast, in Martinique (unexposed group),
  • Participant having been informed of the research,
  • Participant having given his free, informed and express consent,
  • Participant affiliated to a social security scheme.

Exclusion criteria

  • Minor Participant,
  • Participant with a known respiratory or cardiac pathology,
  • Participant with a cognitive state that does not allow him to answer the questionnaire,
  • Participant who refused to participate in the study,
  • Pregnant or breastfeeding women.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

173 participants in 2 patient groups

People exposed to sargassum seaweed stranding
Experimental group
Description:
Participant living on the Atlantic coast of Martinique island (hit by the strandings), close (less than 300 meters) to sargassum seaweed stranding areas: exposed group (85 subjects). Participants will be examined directly at their place of residence. Participants will be examinated two times: * at Visit 1 - Day 0 during the strandings period, * at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
Treatment:
Procedure: FeNO (fractional exhaled nitric oxide)
Procedure: Spirometry
Other: Interrogation
Other: Physical examination
People not exposed to sargassum seaweed stranding
Active Comparator group
Description:
Participant living on the Caribbean coast of Martinique island (not hit by the strandings): unexposed group (85 subjects). Participants will be examined directly at their place of residence. Participants will be examinated two times: * at Visit 1 - Day 0 during the strandings period, * at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
Treatment:
Procedure: FeNO (fractional exhaled nitric oxide)
Procedure: Spirometry
Other: Interrogation
Other: Physical examination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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