PhysiopathologySPIDDNCT05775562
Early Pulmonary Effects of Excursion Deep Diving With Closed-circuit Gas Recycling: SPIDD Study
A study testing Pre and post dive examinations in people with Physiopathology, run by University Hospital, Brest at 1 site in France.
Trial summary
Scuba diving with closed circuit gas rebreathers is currently booming. Initially developed for professional and military diving, this type of diving has become very successful in recreational activities. The possibilities offered by this equipment are immense and reduce the constraints of exploration time and depth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiopathology
- What is being tested?
- Pre and post dive examinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2023to 6 Sep 2024
- 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
- Diver ≥ 18 years old
- Recreational rebreather diver with a recognised qualification (Mixed Gas CCR training or equivalent) and the necessary experience for this type of diving who has scheduled a dive in the 60 metre depth zone
- Diver using his/her own equipment, i.e. a closed circuit rebreather with back lungs meeting CE standards.
- Having a medical certificate of no contraindication to the practice of underwater activities < 1 year issued by an authorised doctor
- Having taken out personal insurance covering this type of activity
- Voluntary and having given his/her express, free and informed consent
- Affiliated to the Social Security
Who cannot join
- Diver refusal
- Known previous respiratory pathology
- Use of medication that may alter pulmonary and/or vascular function as well as inflammatory and haemostasis parameters
- Any temporary contraindication to the practice of scuba diving
- Patient under guardianship or trusteeship
- Immersion beyond 30 metres within 7 days or any scuba diving within the previous 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Scuba diving with closed circuit gas rebreathers is currently booming. Initially developed for professional and military diving, this type of diving has become very successful in recreational activities.
The possibilities offered by this equipment are immense and reduce the constraints of exploration time and depth. More and more divers are seeking to reach depths previously considered unusual or inaccessible in recreational diving, beyond 100 meters. By pushing back these limits, the diver is exposed to new risks which should lead to a reflection on the means of prevention and treatment in case of incident.
Read more
The physiological repercussions of these deep dives are not well known. During daily deep excursions in the 90-120 meter zone, there is a significant reduction in vital capacity on leaving the dive, which persists and worsens the following day.
It seems necessary to confirm the importance of this impairment, never documented before, and to explore its mechanisms. A better knowledge of this respiratory impact could allow to improve the prevention and the preliminary evaluation of the medical aptitude of these divers.
- Conditions
- Physiopathology
- Being tested
- Pre and post dive examinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre and post dive examinationsDiagnostic test
Performing pre-dive examinations:
- EFR by plethysmography cabin
Realization of the examinations the day of the dive:
- Portable Spirometry
- Pulmonary ultrasound
- Cardiac ultrasound
- Measurement of circulating bubbles
- ECG
- Venous blood sampling (biological collection)
- Water balance (Δweight/water intake)
- EFR by plethysmography cabin
- Weight measurement
Realization of the examinations the day after the dive:
- Venous blood sample (biological collection)
- Portable Spirometry
- Pulmonary ultrasound
- Cardiac ultrasound
- Weight measurement
| Study group | Role | What they receive |
|---|---|---|
| Diving arm | Other | The standard arm involves all participants in the study. Subjects will perform pre-dive and post-dive examinations to characterize the respiratory impact of deep water diving Receives: Diagnostic Test: Pre and post dive examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Vital Capacity Measurement before and after diving
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
Measured: Day 0 (before diving)
Variation in Vital Capacity Measurement before and after diving
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
Measured: Day 0 (after diving)
Variation in Vital Capacity Measurement before and after diving
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
Measured: Day +1
Secondary outcomes (44)
Variations in Spirometry data before and after diving
Measurement of SPO2 (%), CVF (L), VEMS (L), VEMS/CVF (%), DEP (L/S) and DEMM (L/S) before and after diving by spirometry
Measured: Day -XX before diving
Variations in Spirometry data before and after diving
Measurement of SPO2 (%), CVF (L), VEMS (L), VEMS/CVF (%), DEP (L/S) and DEMM (L/S) before and after diving by spirometry
Measured: Day 0 (before diving)
Variations in Spirometry data before and after diving
Measurement of SPO2 (%), CVF (L), VEMS (L), VEMS/CVF (%), DEP (L/S) and DEMM (L/S) before and after diving by spirometry
Measured: Day 0 (after diving)
Variations in Spirometry data before and after diving
Measurement of SPO2 (%), CVF (L), VEMS (L), VEMS/CVF (%), DEP (L/S) and DEMM (L/S) before and after diving by spirometry
Measured: Day +1
Variations in plethysmography data before and after diving
Measurement of CV max (L), CVF (L), VRE (L), VRI (L), VT (L), VEMS (L), VR (L) and CPT (L) before and after diving by plethysmography
Measured: Day -XX before Day 0
Variations in plethysmography data before and after diving
Measurement of DEP (L.S), DEM 75 (L/S), DEM 50 (L/s), DEM 25 (L/S) before and after diving by plethysmography
Measured: Day -XX before Day 0
Variations in plethysmography data before and after diving
Measurement of CV max (L), CVF (L), VRE (L), VRI (L), VT (L), VEMS (L), VR (L) and CPT (L) before and after diving by plethysmography
Measured: Day 0 (before diving)
Variations in plethysmography data before and after diving
Measurement of DEP (L.S), DEM 75 (L/S), DEM 50 (L/s), DEM 25 (L/S) before and after diving by plethysmography
Measured: Day 0 (before diving)
Variations in plethysmography data before and after diving
Measurement of CV max (L), CVF (L), VRE (L), VRI (L), VT (L), VEMS (L), VR (L) and CPT (L) before and after diving by plethysmography
Measured: Day 0 (after diving)
Variations in plethysmography data before and after diving
Measurement of DEP (L.S), DEM 75 (L/S), DEM 50 (L/s), DEM 25 (L/S) before and after diving by plethysmography
Measured: Day 0 (after diving)
Variations in plethysmography data before and after diving
Measurement of CV max (L), CVF (L), VRE (L), VRI (L), VT (L), VEMS (L), VR (L) and CPT (L) before and after diving by plethysmography
Measured: Day +1
Variations in plethysmography data before and after diving
Measurement of DEP (L.S), DEM 75 (L/S), DEM 50 (L/s), DEM 25 (L/S) before and after diving by plethysmography
Measured: Day +1
Variations in DLCO before and after diving
Measurement DLCO (mmol/(min*kPa) before and after diving
Measured: Day 0 (before diving)
Variations in DLCO before and after diving
Measurement DLCO (mmol/(min*kPa) before and after diving
Measured: Day 0 (after diving)
Variations in DLCO before and after diving
Measurement DLCO (mmol/(min*kPa) before and after diving
Measured: Day +1
Variations in lung ultrasound (B lines) before and after diving
A B-line count should be performed, which is defined as vertical artefacts, mobile with breathing, continuous, originating from the pleural line and erasing the other artefacts. These artefacts indicate interstitial damage, the importance of which correlates with their number and a very good correlation with the quantity of extrapulmonary water.
Measured: Day 0 (before diving)
Variations in lung ultrasound (B lines) before and after diving
A B-line count should be performed, which is defined as vertical artefacts, mobile with breathing, continuous, originating from the pleural line and erasing the other artefacts. These artefacts indicate interstitial damage, the importance of which correlates with their number and a very good correlation with the quantity of extrapulmonary water.
Measured: Day 0 (after diving)
Variations in lung ultrasound (B lines) before and after diving
A B-line count should be performed, which is defined as vertical artefacts, mobile with breathing, continuous, originating from the pleural line and erasing the other artefacts. These artefacts indicate interstitial damage, the importance of which correlates with their number and a very good correlation with the quantity of extrapulmonary water.
Measured: Day +1
Variations in lung ultrasound (condensations) before and after diving
Ultrasound signs of condensation or pleural effusions should be observed before and after diving.
Measured: Day 0 (before diving)
Variations in lung ultrasound (condensations) before and after diving
Ultrasound signs of condensation or pleural effusions should be observed before and after diving.
Measured: Day 0 (after diving)
Variations in lung ultrasound (condensations) data before and after diving
Ultrasound signs of condensation or pleural effusions should be observed before and after diving.
Measured: Day +1
Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
Pulmonary arterial pressures are assessed by studying pulmonary artery Doppler flow (Acceleration Time) and right ventricular ejection time (RVET) and calculating the Acceleration/RVET ratio.
Measured: Day 0 (before diving)
Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
Pulmonary arterial pressures are assessed by studying pulmonary artery Doppler flow (Acceleration Time) and right ventricular ejection time (RVET) and calculating the Acceleration/RVET ratio.
Measured: Day 0 (after diving)
Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
Pulmonary arterial pressures are assessed by studying pulmonary artery Doppler flow (Acceleration Time) and right ventricular ejection time (RVET) and calculating the Acceleration/RVET ratio.
Measured: Day +1
Variations in right ventricle function data before and after diving
Right ventricular systolic function is assessed by measuring the tricuspid annulus plane systolic excursion (TAPSE) in TM mode and calculating the LV shortening fraction.
Measured: Day 0 (before diving)
Variations in right ventricle function data before and after diving
Right ventricular systolic function is assessed by measuring the tricuspid annulus plane systolic excursion (TAPSE) in TM mode and calculating the LV shortening fraction.
Measured: Day 0 (after diving)
Variations in right ventricle function data before and after diving
Right ventricular systolic function is assessed by measuring the tricuspid annulus plane systolic excursion (TAPSE) in TM mode and calculating the LV shortening fraction.
Measured: Day +1
Variations in decompression (circulating bubbles) data before and after diving
Detection of circulating bubbles by trans-thoracic ultrasound
Measured: Day 0 (before diving)
Variations in decompression (circulating bubbles) data before and after diving
Detection of circulating bubbles by trans-thoracic ultrasound
Measured: Day 0 (after diving)
Variations in biological markers of coagulation activation before and after diving
Measurement from the serum library (venous blood samples) of coagulation factors (TFPI, procoagulant microparticles, Fibrin monomer, PF4, C3a, C5a and platelet count) before and after diving. The analyses remain to be specified according to the results of other ongoing investigations
Measured: Day 0 (before diving)
Variations in biological markers of coagulation activation before and after diving
Measurement from the serum library (venous blood samples) of coagulation factors (TFPI, procoagulant microparticles, Fibrin monomer, PF4, C3a, C5a and platelet count) before and after diving. The analyses remain to be specified according to the results of other ongoing investigations
Measured: Day 0 (after diving)
Variations in biological markers of coagulation activation before and after diving
Measurement from the serum library (venous blood samples) of coagulation factors (TFPI, procoagulant microparticles, Fibrin monomer, PF4, C3a, C5a and platelet count) before and after diving. The analyses remain to be specified according to the results of other ongoing investigations
Measured: Day +1
Variations in biomarkers of lipid peroxidation before and after diving
Measurement from the serum library (venous blood samples) of lipoperoxidation (F2-Isoprostane) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day 0 (before diving)
Variations in biomarkers of lipid peroxidation before and after diving
Measurement from the serum library (venous blood samples) lipoperoxidation (F2-Isoprostane) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day 0 (after diving)
Variations in biomarkers of lipid peroxidation before and after diving
Measurement from the serum library (venous blood samples) lipoperoxidation (F2-Isoprostane) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day +1
Variations in biomarkers of oxidative stress before and after diving
Measurement from the serum library (venous blood samples) of oxidative stress factors before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day 0 (before diving)
Variations in biomarkers of oxidative stress before and after diving
Measurement from the serum library (venous blood samples) of oxidative stress factors before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day 0 (after diving)
Variations in biomarkers of oxidative stress before and after diving
Measurement from the serum library (venous blood samples) of oxidative stress factors (as F2-Isoprostane, 8-isoprostane) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day +1
Variations in biological markers of inflammation before and after diving
Measurement of inflammation factors (CRP and IL1-β) from the serum library (venous blood samples) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day 0 (before diving)
Variations in biological markers of inflammation before and after diving
Measurement of inflammation factors (CRP and IL1-β) from the serum library (venous blood samples) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day 0 (after diving)
Variations in biological markers of inflammation before and after diving
Measurement of inflammation factors (CRP and IL1-β) from the serum library (venous blood samples) before and after the dive. The analyses remain to be specified according to the results of other ongoing investigations.
Measured: Day +1
Variations in water balance before and after diving
Pre- and post-dive water intakes are quantified but no intake restrictions are requested : Weight measured by electronic scale (in kg)
Measured: Day 0 (before diving)
Variations in water balance before and after diving
Pre- and post-dive water intakes are quantified but no intake restrictions are requested : Weight measured by electronic scale (in kg)
Measured: Day 0 (after diving)
Variations in water balance before and after diving
Pre- and post-dive water intakes are quantified but no intake restrictions are requested : Weight measured by electronic scale (in kg)
Measured: Day +1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start19 Sep 2023
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiopathologyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775562
- Sponsor's protocol ID
- 29BRC21.0273
- Acronym
- SPIDD
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pulmonary Effects of Excursion Deep Diving With Closed-circuit Gas Recycling: SPIDD Study
- ClinicalTrials.gov ID
- NCT05775562
- Acronym / sponsor ID
- SPIDD / 29BRC21.0273
- Conditions
- Physiopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 20 Mar 2023 (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.
Scuba diving with closed circuit gas rebreathers is currently booming. Initially developed for professional and military diving, this type of diving has become very successful in recreational activities.
The possibilities offered by this equipment are immense and reduce the constraints of exploration time and depth. More and more divers are seeking to reach depths previously considered unusual or inaccessible in recreational diving, beyond 100 meters. By pushing back these limits, the diver is exposed to new risks which should lead to a reflection on the means of prevention and treatment in case of incident.
The physiological repercussions of these deep dives are not well known. During daily deep excursions in the 90-120 meter zone, there is a significant reduction in vital capacity on leaving the dive, which persists and worsens the following day.
It seems necessary to confirm the importance of this impairment, never documented before, and to explore its mechanisms. A better knowledge of this respiratory impact could allow to improve the prevention and the preliminary evaluation of the medical aptitude of these divers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diving arm | Other | Diagnostic Test: Pre and post dive examinationsThe standard arm involves all participants in the study. Subjects will perform pre-dive and post-dive examinations to characterize the respiratory impact of deep water diving |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diver ≥ 18 years old
- Recreational rebreather diver with a recognised qualification (Mixed Gas CCR training or equivalent) and the necessary experience for this type of diving who has scheduled a dive in the 60 metre depth zone
- Diver using his/her own equipment, i.e. a closed circuit rebreather with back lungs meeting CE standards.
- Having a medical certificate of no contraindication to the practice of underwater activities < 1 year issued by an authorised doctor
- Having taken out personal insurance covering this type of activity
Key exclusion criteria (6 listed)
- Diver refusal
- Known previous respiratory pathology
- Use of medication that may alter pulmonary and/or vascular function as well as inflammatory and haemostasis parameters
- Any temporary contraindication to the practice of scuba diving
- Patient under guardianship or trusteeship
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 |
|---|---|---|
| Pre and post dive examinationsPerforming pre-dive examinations: - EFR by plethysmography cabin Realization of the examinations the day of the dive: * Portable Spirometry * Pulmonary ultrasound * Cardiac ultrasound * Measurement of circulating bubbles * ECG * Venous blood sampling (biological collection) * Water balance (Δweight/water intake) * EFR by plethysmography cabin * Weight measurement Realization of the examinations the day after the dive: * Venous blood sample (biological collection) * Portable Spirometry * Pulmonary ultrasound * Cardiac ultrasound * Weight measurement | Diagnostic test | Diving arm |
Primary outcome
Variation in Vital Capacity Measurement before and after diving
Time frame: Day 0 (before diving)
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
Variation in Vital Capacity Measurement before and after diving
Time frame: Day 0 (after diving)
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
Variation in Vital Capacity Measurement before and after diving
Time frame: Day +1
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
44 secondary outcomes
Variations in Spirometry data before and after diving
Time frame: Day -XX before diving
Variations in Spirometry data before and after diving
Time frame: Day 0 (before diving)
Variations in Spirometry data before and after diving
Time frame: Day 0 (after diving)
Variations in Spirometry data before and after diving
Time frame: Day +1
Variations in plethysmography data before and after diving
Time frame: Day -XX before Day 0
Variations in plethysmography data before and after diving
Time frame: Day -XX before Day 0
Variations in plethysmography data before and after diving
Time frame: Day 0 (before diving)
Variations in plethysmography data before and after diving
Time frame: Day 0 (before diving)
Variations in plethysmography data before and after diving
Time frame: Day 0 (after diving)
Variations in plethysmography data before and after diving
Time frame: Day 0 (after diving)
Variations in plethysmography data before and after diving
Time frame: Day +1
Variations in plethysmography data before and after diving
Time frame: Day +1
Variations in DLCO before and after diving
Time frame: Day 0 (before diving)
Variations in DLCO before and after diving
Time frame: Day 0 (after diving)
Variations in DLCO before and after diving
Time frame: Day +1
Variations in lung ultrasound (B lines) before and after diving
Time frame: Day 0 (before diving)
Variations in lung ultrasound (B lines) before and after diving
Time frame: Day 0 (after diving)
Variations in lung ultrasound (B lines) before and after diving
Time frame: Day +1
Variations in lung ultrasound (condensations) before and after diving
Time frame: Day 0 (before diving)
Variations in lung ultrasound (condensations) before and after diving
Time frame: Day 0 (after diving)
Variations in lung ultrasound (condensations) data before and after diving
Time frame: Day +1
Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
Time frame: Day 0 (before diving)
Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
Time frame: Day 0 (after diving)
Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
Time frame: Day +1
Variations in right ventricle function data before and after diving
Time frame: Day 0 (before diving)
Variations in right ventricle function data before and after diving
Time frame: Day 0 (after diving)
Variations in right ventricle function data before and after diving
Time frame: Day +1
Variations in decompression (circulating bubbles) data before and after diving
Time frame: Day 0 (before diving)
Variations in decompression (circulating bubbles) data before and after diving
Time frame: Day 0 (after diving)
Variations in biological markers of coagulation activation before and after diving
Time frame: Day 0 (before diving)
Variations in biological markers of coagulation activation before and after diving
Time frame: Day 0 (after diving)
Variations in biological markers of coagulation activation before and after diving
Time frame: Day +1
Variations in biomarkers of lipid peroxidation before and after diving
Time frame: Day 0 (before diving)
Variations in biomarkers of lipid peroxidation before and after diving
Time frame: Day 0 (after diving)
Variations in biomarkers of lipid peroxidation before and after diving
Time frame: Day +1
Variations in biomarkers of oxidative stress before and after diving
Time frame: Day 0 (before diving)
Variations in biomarkers of oxidative stress before and after diving
Time frame: Day 0 (after diving)
Variations in biomarkers of oxidative stress before and after diving
Time frame: Day +1
Variations in biological markers of inflammation before and after diving
Time frame: Day 0 (before diving)
Variations in biological markers of inflammation before and after diving
Time frame: Day 0 (after diving)
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 17 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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?
A study testing Pre and post dive examinations in people with Physiopathology, run by University Hospital, Brest at 1 site in France.
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 7 inclusion and 6 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 17 Jun 2026. 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?
Variation in Vital Capacity Measurement before and after diving (time frame: Day 0 (before diving)). The study lists 3 primary outcomes in all. 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 17 Jun 2026.