Sickle Cell DiseasePhase 3HBOT-SCDNCT05289700
Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD)
A Phase 3 study testing HBOT in Hyperbaric chamber in people with Sickle Cell Disease and Hyperbaric Oxygen Therapy, run by University Hospital, Geneva at 3 sites in 2 countries.
Trial summary
This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level in the treatment of SCD-VOC. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sickle Cell Disease, Hyperbaric Oxygen Therapy, Vaso-occlusive Crisis
- What is being tested?
- HBOT in Hyperbaric chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Sep 2022to 31 Mar 2025
- Phase
- Phase 3
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 8 or over;
- Diagnosed with a major SCD disorder (SS, SC, Hb O Arab, Sβ0 and Sβ+ -thalassemias);
- Presentation of a Vaso-Occlusive Crisis (VOC), with or without Acute Chest Syndrome,
- Unresponsive to level 2 analgesics (WHO classification)
- Which fulfils the criteria necessary for consultation at an ED;
- Ability to carry out the Valsalva manoeuvre;
- Ability to give informed consent and sign a written informed consent form (consent and signature of legal guardian authorised).
Who cannot join
- Pregnancy;
- Indication for artificial ventilation (non-invasive ventilation/oro-tracheal intubation);
- Proven contraindication for HBOT established by a physician responsible for hyperbaric medicine;
- Anomaly in the results of prior transcranial Doppler (TCD) ultrasound (> 200 cm/sec) or a previous history of stroke (but TCD will not be performed for the study);
- Patients requiring more than 2 l/min of normobaric oxygen in order to maintain an SpO2 ≥ 92%.
Trial locations and contacts
3 sites in 2 countries.
Jacques Serratrice, Dr contact
3 sites in 2 countries
France2 sites, 2 recruiting
- Not yet recruiting
Hospices civils de Lyon
Lyon
Giovanna Cannas, MD
- Not yet recruiting
Centre de compétences Sd drépanocytaires
Toulouse
Pierre Cougoul, MD
Switzerland1 site, 1 recruiting
- Recruiting
HUG
Geneva, 1211
jerome Stirnemann, MD, +41795534408, jerome.stirnemann@hcuge.ch
About this study
Official title: Multicentric, Double-blind, Randomised Controled Trial of Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD) After 8 Years Old
This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level in the treatment of SCD-VOC.
Read the detailed description
Background: Sickle cell disease (SCD) is one of the most common genetic diseases in the world, affecting approximately 310,000 births each year and causing >100,000 deaths. Vaso-occlusive crisis (VOC) is the most frequent complication of SCD, leading to bone pain, thoracic pain and/or abdominal spasms and is the main cause of death in patients with SCD. It is linked to sickling which is often triggered by internal and external environmental conditions such as acidosis, cold, dehydration, hyperthermia, infection and especially hypoxia. Sickling is initially reversible if local oxygenation supply and conditions are improved.
Rationale: The use of hyperbaric oxygen therapy (HBOT) should enable the patient's tissues to receive the extra oxygen necessary by increasing the amount of dissolved O2 in blood which in turn would limit sickling. A pilot study of 9 patients showed the potential positive effects of HBOT on VOC induced pain. International guidelines indicate that SCD-induced VOC is one of the potential indications for HBOT, even though the evidence available is weak.
Aim and objectives: To demonstrate the analgesic effect of HBOT for VOC and to analyse the procedure's safety, impact on the biological markers of SCD-induced VOC, progression of SCD and cost-effectiveness.
Methodology: This study will be a multicentric, double-blind, randomised controlled trial. Any patient presenting at one of the participating centres' Emergency Departments (EDs) with VOC is eligible to be evaluated, included and randomized. Inclusion criteria: Patients aged 8 years or over with a major SCD, having a VOC non-responsive to level 2 analgesics (WHO classification), with or without Acute Chest Syndrome (ACS). Exclusion criteria: Pregnancy, indication for artificial ventilation, proven contraindication for HBO, blood velocity > 200 cm/sec previously measured with transcranial Doppler, previous history of stroke, patient requiring more than 2 l/min of normobaric oxygen in order to achieve an SpO2 (peripheral oxygen saturation) ≥ 92%. Patients with exclusion criteria, although precluded from the randomisation process, will however be eligible to undergo the HBOT intervention and become part of the cohort. Measurements and procedures: In all cases, included patients will receive usual care for VOC, including hydration, analgesics (patient-controlled analgesia with morphine), normobaric oxygen therapy and where medically indicated, antibiotic therapy and/or transfusions. Within 4 to 12 hours of their initial consultation at their hospital's ED, patients who have agreed to participate in the study will be randomised between the HBOT intervention group (2 Atmosphere Absolute pressure [ATA], 95 min, FIO2 = 1) and the placebo group (1.3 ATA, 95 min, FIO2 = 0.21). Patients will undergo a first session in the hyperbaric chamber and then return to their ward. The second (and third) session (for both groups) will systematically take place within 24 h (max. 36 h) of the first session. If the visual analogue scale (VAS) pain score is ≤ 2 without the use of level 3 analgesics at the standard dosage, subsequent sessions will be cancelled. Difference in the visual analogue scale (VAS) pain score before and after HBOT and other outcomes will be compared between the intervention and placebo groups. A superiority of HBOT compared placebo group in VOC should be demonstrated, with decrease of pain, length of stay and cost.
Expected results and their impact: Expected benefits of HBOT are the reduction of: pain experienced, duration of the crisis, number of transfusions required, the number of morphine doses, reduction of length of stay and reduction in the frequency of ACSs and VOCs.
- Being tested
- HBOT in Hyperbaric chamber, Hyperbaric chamber for placebo
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOT in Hyperbaric chamberDevice
Also called Hyperbaric Oxygen Therapy
HBOT is the administration of oxygen (FIO2 = 100%) at a pressure higher than atmospheric pressure (2 ATA). The pressure increase is achieved by introducing compressed air into the hyperbaric chamber. This study will use a hyperbaric chamber that is already marketed, licensed and used in other diseases.
Hyperbaric chamber for placeboDevice
Also called Placebo Comparator
Hyperbaric chamber is the same chamber used for HBOT, but here with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers. All other aspects of the procedure are identical to those of the intervention. As in the intervention arm, there will be a compression period (although shorter), of 5 min, followed by 85 min at 1.3 ATA, then a decompression period of 5 min (total duration of 95 min).
| Study group | Role | What they receive |
|---|---|---|
| HBOT intervention group (2 ATA, 95 min, FIO2=1) | Experimental | Hyperbaric Oxygen Therapy (HBOT) is the administration of oxygen at a pressure higher than atmospheric pressure (2 ATA). By breathing pure oxygen at twice the atmospheric pressure, its concentration in the blood is multiplied by nearly ten times. This allows a greater oxygen concentration in poorly vascularised areas of the body. Receives: Device: HBOT in Hyperbaric chamber |
| placebo group (1.3 ATA, 95 min, FIO2=0.21) | Placebo comparator | Hyperbaric chamber is the same chamber used for HBOT, but with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers. Receives: Device: Hyperbaric chamber for placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of visual analogue scale (VAS) pain score
The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Change = (Hour 6 VAS score - Baseline VAS score) ; Difference in the global visual analogue scale (VAS) pain score evaluated immediately before (in the ED ; H0) and 6 hrs after (on the ward) the HBO therapy/placebo session (H6).
Measured: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)
Change from baseline of a number of patients with composite outcome (VAS pain score >4 and/or mean morphine dosage > 1mg/h IV)
The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Change = Number of patient with composite score at H6 - Number of patient with composite score at H0.
Measured: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)
Secondary outcomes (6)
Change from baseline of the mean morphine dosage treatment (mg/h IV) at H6
Change in mean hourly concentration dosage of morphine between the mean concentration before HBOT Session (H0) and the mean concentration during the 4 hours after session (H6) [morphine concentration during session (2 hours) is not included in the calculation]. In case of treatment with oral morphine, an equivalent of IV doses will be used.
Measured: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)
Change from baseline of the mean morphine dosage treatment (mg/h IV) at H24
Change in mean hourly concentration dosage of morphine between the mean concentration before HBOT Session (H0) and the mean concentration during the 22 hours after session (H24) [morphine concentration during session (2 hours) is not included in the calculation]. In case of treatment with oral morphine, an equivalent of IV doses will be used.
Measured: Baseline (before HBOT session ; H0) and 24th hour after the start of the HBOT session (H24)
time to discontinuation of IV opioids
Time between admission and discontinuation of intra-venous opioids, during hospitalisation before discharge and/or rehabilitation transfer
Measured: From admission date until discharge date (up to 1 month)
length of hospital stay
Number of days between admission and hospital discharge
Measured: From admission date until discharge date (up to 1 month)
Number of patients experiencing relief from pain (ie reduction of VAS>30%) at Hour 6
The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Number of patient with decreasing of VAS pain score>30% between Hour 6 and baseline (before HBOT session ; H0).
Measured: 6th hour after the start of the HBOT session (H6)
Number of patients experiencing relief from pain (ie reduction of VAS>30%) at Hour 24
The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Number of patient with decreasing of VAS pain score>30% between Hour 24 and baseline (before HBOT session ; H0)
Measured: 24th hour after the start of the HBOT session (H24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start15 Sep 2022
- Primary completion15 Sep 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention is a treatment with Hyperbaric Oxygen Therapy in Hyperbaric chamber. Placebo is entry in hyperbaric chamber but without oxygen and with a minimal pression. Within 4 hrs (or at the latest 12 hrs) of their initial consultation at their hospital's ED, patients who have agreed to participate in the study will be randomised between the HBOT intervention group (2 ATA, 95 min, FIO2=1) and the placebo group (1.3 ATA, 95 min, FIO2=0.21). Patients undergo a first session (HBOT/placebo) in the hyperbaric chamber and then return to their ward.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse, Hospices Civils de Lyon
- Responsible party
- Principal investigator, Jerome Stirnemann, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289700
- Sponsor's protocol ID
- 2019-01707
- Other IDs
- 2019
- Acronym
- HBOT-SCD
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Double-blind, Randomised Controled Trial of Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD) After 8 Years Old
- ClinicalTrials.gov ID
- NCT05289700
- Acronym / sponsor ID
- HBOT-SCD / 2019-01707
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse, Hospices Civils de Lyon
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Mar 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.
This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level in the treatment of SCD-VOC.
Detailed description
Background: Sickle cell disease (SCD) is one of the most common genetic diseases in the world, affecting approximately 310,000 births each year and causing >100,000 deaths. Vaso-occlusive crisis (VOC) is the most frequent complication of SCD, leading to bone pain, thoracic pain and/or abdominal spasms and is the main cause of death in patients with SCD. It is linked to sickling which is often triggered by internal and external environmental conditions such as acidosis, cold, dehydration, hyperthermia, infection and especially hypoxia. Sickling is initially reversible if local oxygenation supply and conditions are improved.
Rationale: The use of hyperbaric oxygen therapy (HBOT) should enable the patient's tissues to receive the extra oxygen necessary by increasing the amount of dissolved O2 in blood which in turn would limit sickling. A pilot study of 9 patients showed the potential positive effects of HBOT on VOC induced pain. International guidelines indicate that SCD-induced VOC is one of the potential indications for HBOT, even though the evidence available is weak.
Aim and objectives: To demonstrate the analgesic effect of HBOT for VOC and to analyse the procedure's safety, impact on the biological markers of SCD-induced VOC, progression of SCD and cost-effectiveness.
Methodology: This study will be a multicentric, double-blind, randomised controlled trial. Any patient presenting at one of the participating centres' Emergency Departments (EDs) with VOC is eligible to be evaluated, included and randomized. Inclusion criteria: Patients aged 8 years or over with a major SCD, having a VOC non-responsive to level 2 analgesics (WHO classification), with or without Acute Chest Syndrome (ACS). Exclusion criteria: Pregnancy, indication for artificial ventilation, proven contraindication for HBO, blood velocity > 200 cm/sec previously measured with transcranial Doppler, previous history of stroke, patient requiring more than 2 l/min of normobaric oxygen in order to achieve an SpO2 (peripheral oxygen saturation) ≥ 92%. Patients with exclusion criteria, although precluded from the randomisation process, will however be eligible to undergo the HBOT intervention and become part of the cohort. Measurements and procedures: In all cases, included patients will receive usual care for VOC, including hydration, analgesics (patient-controlled analgesia with morphine), normobaric oxygen therapy and where medically indicated, antibiotic therapy and/or transfusions. Within 4 to 12 hours of their initial consultation at their hospital's ED, patients who have agreed to participate in the study will be randomised between the HBOT intervention group (2 Atmosphere Absolute pressure [ATA], 95 min, FIO2 = 1) and the placebo group (1.3 ATA, 95 min, FIO2 = 0.21). Patients will undergo a first session in the hyperbaric chamber and then return to their ward. The second (and third) session (for both groups) will systematically take place within 24 h (max. 36 h) of the first session. If the visual analogue scale (VAS) pain score is ≤ 2 without the use of level 3 analgesics at the standard dosage, subsequent sessions will be cancelled. Difference in the visual analogue scale (VAS) pain score before and after HBOT and other outcomes will be compared between the intervention and placebo groups. A superiority of HBOT compared placebo group in VOC should be demonstrated, with decrease of pain, length of stay and cost.
Expected results and their impact: Expected benefits of HBOT are the reduction of: pain experienced, duration of the crisis, number of transfusions required, the number of morphine doses, reduction of length of stay and reduction in the frequency of ACSs and VOCs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention is a treatment with Hyperbaric Oxygen Therapy in Hyperbaric chamber. Placebo is entry in hyperbaric chamber but without oxygen and with a minimal pression. Within 4 hrs (or at the latest 12 hrs) of their initial consultation at their hospital's ED, patients who have agreed to participate in the study will be randomised between the HBOT intervention group (2 ATA, 95 min, FIO2=1) and the placebo group (1.3 ATA, 95 min, FIO2=0.21). Patients undergo a first session (HBOT/placebo) in the hyperbaric chamber and then return to their ward.
| Arm | Type | Receives |
|---|---|---|
| HBOT intervention group (2 ATA, 95 min, FIO2=1) | Experimental | Device: HBOT in Hyperbaric chamberHyperbaric Oxygen Therapy (HBOT) is the administration of oxygen at a pressure higher than atmospheric pressure (2 ATA). By breathing pure oxygen at twice the atmospheric pressure, its concentration in the blood is multiplied by nearly ten times. This allows a greater oxygen concentration in poorly vascularised areas of the body. |
| placebo group (1.3 ATA, 95 min, FIO2=0.21) | Placebo comparator | Device: Hyperbaric chamber for placeboHyperbaric chamber is the same chamber used for HBOT, but with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 8 or over;
- Diagnosed with a major SCD disorder (SS, SC, Hb O Arab, Sβ0 and Sβ+ -thalassemias);
- Presentation of a Vaso-Occlusive Crisis (VOC), with or without Acute Chest Syndrome,
- Unresponsive to level 2 analgesics (WHO classification)
- Which fulfils the criteria necessary for consultation at an ED;
Key exclusion criteria (5 listed)
- Pregnancy;
- Indication for artificial ventilation (non-invasive ventilation/oro-tracheal intubation);
- Proven contraindication for HBOT established by a physician responsible for hyperbaric medicine;
- Anomaly in the results of prior transcranial Doppler (TCD) ultrasound (> 200 cm/sec) or a previous history of stroke (but TCD will not be performed for the study);
- Patients requiring more than 2 l/min of normobaric oxygen in order to maintain an SpO2 ≥ 92%.
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 |
|---|---|---|
| HBOT in Hyperbaric chamberAlso: Hyperbaric Oxygen TherapyHBOT is the administration of oxygen (FIO2 = 100%) at a pressure higher than atmospheric pressure (2 ATA). The pressure increase is achieved by introducing compressed air into the hyperbaric chamber. This study will use a hyperbaric chamber that is already marketed, licensed and used in other diseases. | Device | HBOT intervention group (2 ATA, 95 min, FIO2=1) |
| Hyperbaric chamber for placeboAlso: Placebo ComparatorHyperbaric chamber is the same chamber used for HBOT, but here with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers. All other aspects of the procedure are identical to those of the intervention. As in the intervention arm, there will be a compression period (although shorter), of 5 min, followed by 85 min at 1.3 ATA, then a decompression period of 5 min (total duration of 95 min). | Device | placebo group (1.3 ATA, 95 min, FIO2=0.21) |
Primary outcome
Change from baseline of visual analogue scale (VAS) pain score
Time frame: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)
The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Change = (Hour 6 VAS score - Baseline VAS score) ; Difference in the global visual analogue scale (VAS) pain score evaluated immediately before (in the ED ; H0) and 6 hrs after (on the ward) the HBO therapy/placebo session (H6).
Change from baseline of a number of patients with composite outcome (VAS pain score >4 and/or mean morphine dosage > 1mg/h IV)
Time frame: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)
The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Change = Number of patient with composite score at H6 - Number of patient with composite score at H0.
6 secondary outcomes
Change from baseline of the mean morphine dosage treatment (mg/h IV) at H6
Time frame: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)
Change from baseline of the mean morphine dosage treatment (mg/h IV) at H24
Time frame: Baseline (before HBOT session ; H0) and 24th hour after the start of the HBOT session (H24)
time to discontinuation of IV opioids
Time frame: From admission date until discharge date (up to 1 month)
length of hospital stay
Time frame: From admission date until discharge date (up to 1 month)
Number of patients experiencing relief from pain (ie reduction of VAS>30%) at Hour 6
Time frame: 6th hour after the start of the HBOT session (H6)
Number of patients experiencing relief from pain (ie reduction of VAS>30%) at Hour 24
Time frame: 24th hour after the start of the HBOT session (H24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Jacques Serratrice, Dr contact
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HBOT in Hyperbaric chamber in people with Sickle Cell Disease and Hyperbaric Oxygen Therapy, run by University Hospital, Geneva at 3 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Stirnemann, Dr (+ 41 22 372 92 02, jerome.stirnemann@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of visual analogue scale (VAS) pain score (time frame: Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)). The study lists 2 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 2 Nov 2022.