Obstructive Ventilatory DisordersSÉSARNCT05564546

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

A study testing FeNO (fractional exhaled nitric oxide), Spirometry and Physical examination in people with Obstructive Ventilatory Disorders, run by University Hospital Center of Martinique at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Obstructive Ventilatory Disorders
What is being tested?: FeNO (fractional exhaled nitric oxide), Spirometry and Physical examination
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: 1 siteFrance
Study dates: 18 Aug 2022to 28 Mar 2023
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

France1 site

University Hospital Center of Martinique
Fort-de-France, 97261

Other trials in France

About this study

Official title: Impact of Hydrogen Sulfide on Lung Health: 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

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.

Conditions: Obstructive Ventilatory Disorders
Being tested: FeNO (fractional exhaled nitric oxide), Spirometry, Physical examination, Interrogation
Keywords: sargassum seaweed, exposure to H2S, pulmonary effects, H2S poisoning, fractional exhaled nitric oxide, spirometry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FeNO (fractional exhaled nitric oxide)Procedure or surgery
FeNO measurement is a marker of airway inflammation. It is a non-invasive examination for the patient, easy to perform for healthcare personnel, the measurement of NO in exhaled air is one of the only non-invasive and reproducible examinations allowing the detection of inflammation airways.
The FeNO will be measured by an electrochemical NO analyzer of the NiOx Vero type (Circassia, The Surgical Company) and expressed in particles per billion (ppb). The objective and reproducible measurement of NO production by the bronchial mucosa is a reflection of the degree of airway inflammation. The measurement of exhaled NO is part of diagnostic health technologies aimed at quantifying airway inflammation, especially in asthmatic patients.
FeNO is considered normal for values of 16-25 ppb. A FeNO value > 25 ppb will be a reason for consultation at the Martinique Hospital for additional assessment.
SpirometryProcedure or surgery
Spirometry tests will assess lung function. It is a safe and painless test to measure lung volumes and expiratory flows.
Ventilatory function is assessed by simple spirometry parameters such as forced expiratory volume in the first second (FEV1, in litres), vital capacity (CV, in litres), and the FEV1/CV ratio.
The results of the spirometry will be compared with the theoretical or predicted values calculated according to age, sex, height.The FEV1/CV ratio as a percentage is an indicator of the level of bronchial obstruction.
Spirometry is considered normal for CV values ≥80% and FEV1/FVC ≥0.70 of the predicted value. A value of CV <80% or FEV <80% of the predicted value will be a reason for consultation at the Martinique hospital for additional assessment.
Physical examinationOther
A pulmonary clinical examination will be carried out by the investigator, including:
- Cough,
- Sputum,
- Vesicular murmur (MV),
- Added noises (BSA),
- Vocal vibrations (VV),
- Tympanism,
- Dullness,
- Signs of acute respiratory distress (ARD),
- …
InterrogationOther
Participants will undergo an interview with the medical team to collect the following information in particular:
Age, size, sex, medical history, smoking status, current treatments, potential symptoms, date of first symptoms, clinical manifestations experienced (respiratory, digestive, neurological, cardiac, psychiatric, visual, skin disorders, etc.) place of residence, concentration H2S in ppm on the site, presence of sand mist in the environment, etc.

Study groups in NCT05564546
Study group	Role	What they receive
People exposed to sargassum seaweed stranding	Experimental	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. Receives: Procedure: FeNO (fractional exhaled nitric oxide); Procedure: Spirometry; Other: Physical examination; Other: Interrogation
People not exposed to sargassum seaweed stranding	Active comparator	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. Receives: Procedure: FeNO (fractional exhaled nitric oxide); Procedure: Spirometry; Other: Physical examination; Other: Interrogation

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare the expired fractions of nitric oxide between people exposed and not exposed to toxic gases from sargassum in Martinique
The primary endpoint of the study will be FeNO (exhaled fraction of nitric oxide). FeNO measurement is a marker of airway inflammation. This is a test used routinely for the non-invasive detection and quantification of bronchial inflammation.
FeNO is considered normal for values of 16-25 ppb. A FeNO value > 25 ppb will be a reason for consultation at the Martinique Hospital for additional assessment.
Measured: 6 months

Secondary outcomes (2)

Compare the pulmonary effects (spirometric) related to the emission of toxic gases from Sargassum between people exposed and those not exposed to Sargassum in Martinique.
The pulmonary effects related to the emission of toxic gases from Sargassum between exposed and non-exposed people will be compared based on the slow and forced spirometry measurements.
Spirometry tests will assess lung function. It is a safe and painless test to measure lung volumes and expiratory flows.
Ventilatory function is assessed by simple spirometry parameters such as forced expiratory volume in the first second (FEV1, in litres), vital capacity (CV, in litres), and the FEV1/CV ratio.
The results of the spirometry will be compared with the theoretical or predicted values calculated according to age, sex, height.The FEV1/CV ratio as a percentage is an indicator of the level of bronchial obstruction.
Spirometry is considered normal for CV values ≥80% and FEV1/FVC ≥0.70 of the predicted value. A value of CV <80% or FEV <80% of the predicted value will be a reason for consultation at the Martinique hospital for additional assessment.
Measured: 6 months
Compare the pulmonary effects (clinical) related to the emission of toxic gases from Sargassum between people exposed and those not exposed to Sargassum in Martinique.
The pulmonary effects related to the emission of toxic gases from Sargassum between exposed and non-exposed people will be compared based on the clinical examination results.
A pulmonary clinical examination will be carried out by the investigator, including:
Cough, Sputum, Vesicular murmur (MV), Added noises (BSA), Vocal vibrations (VV), Tympanism, Dullness, Signs of acute respiratory distress (ARD), Respiratory rate, SpO2…
In addition, participants will undergo an interview with the medical team to collect the following information in particular:
Age, size, sex, medical history, smoking status, current treatments, potential symptoms, date of first symptoms, clinical manifestations experienced (respiratory, digestive, neurological, cardiac, psychiatric, visual, skin disorders, etc.) place of residence, concentration H2S in ppm on the site, presence of sand mist in the environment, etc.
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202228 Mar 2023

First posted3 Oct 2022
Study start18 Aug 2022
Primary completion28 Mar 2023
Study completion28 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obstructive Ventilatory DisordersStudies 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: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is a prospective, longitudinal study, of exposed/non-exposed type, descriptive, comparative and monocentric
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05564546
Sponsor's protocol ID: 22_RIPH2-04
Other IDs: 2022-A01382-41
Acronym: SÉSAR
Status last verified: Aug 2022
First submitted: 13 Sep 2022
Last updated: 13 Dec 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Hydrogen Sulfide on Lung Health: 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
ClinicalTrials.gov ID: NCT05564546
Acronym / sponsor ID: SÉSAR / 22_RIPH2-04
Conditions: Obstructive Ventilatory Disorders
Keywords: sargassum seaweed, exposure to H2S, pulmonary effects, H2S poisoning, fractional exhaled nitric oxide, spirometry
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: University Hospital Center of MartiniqueUniversity, hospital or other
Study start: 18 Aug 2022 (actual)
Primary completion: 28 Mar 2023 (actual)
Study completion: 28 Mar 2023 (actual)
First posted: 3 Oct 2022 (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.

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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a prospective, longitudinal study, of exposed/non-exposed type, descriptive, comparative and monocentric

Arm	Type	Receives
People exposed to sargassum seaweed stranding	Experimental	Procedure: FeNO (fractional exhaled nitric oxide), Procedure: Spirometry, Other: Physical examination, Other: InterrogationParticipant 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.
People not exposed to sargassum seaweed stranding	Active comparator	Procedure: FeNO (fractional exhaled nitric oxide), Procedure: Spirometry, Other: Physical examination, Other: InterrogationParticipant 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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,

Key exclusion criteria (5 listed)

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.

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
FeNO (fractional exhaled nitric oxide)FeNO measurement is a marker of airway inflammation. It is a non-invasive examination for the patient, easy to perform for healthcare personnel, the measurement of NO in exhaled air is one of the only non-invasive and reproducible examinations allowing the detection of inflammation airways. The FeNO will be measured by an electrochemical NO analyzer of the NiOx Vero type (Circassia, The Surgical Company) and expressed in particles per billion (ppb). The objective and reproducible measurement of NO production by the bronchial mucosa is a reflection of the degree of airway inflammation. The measurement of exhaled NO is part of diagnostic health technologies aimed at quantifying airway inflammation, especially in asthmatic patients. FeNO is considered normal for values of 16-25 ppb. A FeNO value > 25 ppb will be a reason for consultation at the Martinique Hospital for additional assessment.	Procedure or surgery	People exposed to sargassum seaweed stranding, People not exposed to sargassum seaweed stranding
SpirometrySpirometry tests will assess lung function. It is a safe and painless test to measure lung volumes and expiratory flows. Ventilatory function is assessed by simple spirometry parameters such as forced expiratory volume in the first second (FEV1, in litres), vital capacity (CV, in litres), and the FEV1/CV ratio. The results of the spirometry will be compared with the theoretical or predicted values calculated according to age, sex, height.The FEV1/CV ratio as a percentage is an indicator of the level of bronchial obstruction. Spirometry is considered normal for CV values ≥80% and FEV1/FVC ≥0.70 of the predicted value. A value of CV <80% or FEV <80% of the predicted value will be a reason for consultation at the Martinique hospital for additional assessment.	Procedure or surgery	People exposed to sargassum seaweed stranding, People not exposed to sargassum seaweed stranding
Physical examinationA pulmonary clinical examination will be carried out by the investigator, including: * Cough, * Sputum, * Vesicular murmur (MV), * Added noises (BSA), * Vocal vibrations (VV), * Tympanism, * Dullness, * Signs of acute respiratory distress (ARD), * …	Other	People exposed to sargassum seaweed stranding, People not exposed to sargassum seaweed stranding
InterrogationParticipants will undergo an interview with the medical team to collect the following information in particular: Age, size, sex, medical history, smoking status, current treatments, potential symptoms, date of first symptoms, clinical manifestations experienced (respiratory, digestive, neurological, cardiac, psychiatric, visual, skin disorders, etc.) place of residence, concentration H2S in ppm on the site, presence of sand mist in the environment, etc.	Other	People exposed to sargassum seaweed stranding, People not exposed to sargassum seaweed stranding

Primary outcome

Compare the expired fractions of nitric oxide between people exposed and not exposed to toxic gases from sargassum in Martinique
Time frame: 6 months
The primary endpoint of the study will be FeNO (exhaled fraction of nitric oxide). FeNO measurement is a marker of airway inflammation. This is a test used routinely for the non-invasive detection and quantification of bronchial inflammation. FeNO is considered normal for values of 16-25 ppb. A FeNO value > 25 ppb will be a reason for consultation at the Martinique Hospital for additional assessment.

2 secondary outcomes

Compare the pulmonary effects (spirometric) related to the emission of toxic gases from Sargassum between people exposed and those not exposed to Sargassum in Martinique.
Time frame: 6 months
Compare the pulmonary effects (clinical) related to the emission of toxic gases from Sargassum between people exposed and those not exposed to Sargassum in Martinique.
Time frame: 6 month

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 13 Dec 2023.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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 13 Dec 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 France. 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?

Compare the expired fractions of nitric oxide between people exposed and not exposed to toxic gases from sargassum in Martinique (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564546.

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 13 Dec 2023.