NCT05564546: SÉSAR

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

Completed NA Last updated 13 December 2023

What this trial tests

NA trial testing FeNO (fractional exhaled nitric oxide) in Obstructive Ventilatory Disorders in 173 participants. Completed in 28 March 2023.

Timeline

18 August 2022

Primary endpoint
28 March 2023

28 March 2023

Quick facts

Lead sponsor	University Hospital Center of Martinique
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	173
Start date	18 August 2022
Primary completion	28 March 2023
Estimated completion	28 March 2023
Sites	1 location across France

Drugs / interventions tested

• FeNO (fractional exhaled nitric oxide)
• Spirometry
• Physical examination
• Interrogation

Conditions studied

• Obstructive Ventilatory Disorders — all drugs for Obstructive Ventilatory Disorders →

Sponsor

University Hospital Center of Martinique

Who can join

18 and older, any sex, with Obstructive Ventilatory Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.