Hyperbaric OxygenationNCT06401941
Selected Lysosomal Enzyme Activities and the Oxidant-antioxidant Balance in Hyperbaric Oxygen Condition.
A study testing Hyperbaric Oxygen Therapy in people with Hyperbaric Oxygenation and Oxygen Toxicity, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
The aim of the research project was to investigate the effects of hyperbaric oxygen (HBO) treatment on the redox equilibrium in individuals with different pathological conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperbaric Oxygenation, Oxygen Toxicity, Antioxidants
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePoland
- Study dates
- 26 Apr 2016to 31 Dec 2020
- 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
- signed informed consent form for participation in the study
Who cannot join
- other pathological conditions (disorders, wounds, diseases)
- bad feeling of the participant on the day of the study,
- refraining from smoking, drinking alcohol, and the consumption of any dietary supplements that can affect the oxidant-antioxidant balance.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-092
About this study
Official title: The Impact of Staying in Hyperbaric Oxygen Conditions on the Oxidant-antioxidant Balance and the Activities of Selected Lysosomal Enzymes
The aim of the research project was to investigate the effects of hyperbaric oxygen (HBO) treatment on the redox equilibrium in individuals with different pathological conditions. Both hyperbaric oxygenation and the pathological condition are associated with redox imbalance (oxidative stress), however, HBO is successfully used in the treatment of chronic wounds, e.g., diabetic foot syndrome, as well as in sudden and acute hearing loss, e.g., acute acoustic trauma or idiopathic sudden sensorineural hearing loss.
Read the detailed description
The study involed in sudden sensorineural hearing loss (SSNHL) patients, individuals with difficult-to-heal skin wounds following mechanical injuries, and diabetic foot patients. HBO therapy, which involved inhalation of 100% oxygen at a pressure of 2.5 atm, consisted of 14-30 sessions depending on the clinical case. The study material was venous blood drawn three times: before and after the first session, and after the last HBO procedure. The following variables were evaluated: the concentrations of thiobarbituric acid reactive substances (TBARS), malondialdehyde (MDA) and conjugated dienes (CD) in plasma and erythrocytes, the activities of catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidase (GPx) in erythrocytes, as well as, blood counts.
- Being tested
- Hyperbaric Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
Also called HBO treatment, Hyperbaric Oxygenation
HBO session includes three 20-minute inhalations of pure oxygen in a hyperbaric chamber utilizing specially fitted face masks for each patient. The session is conducted as follows: 10 minutes compression of up to 2.5 atm (0.25 MPa), inhalation of 100% oxygen for 20 minutes, a 5-minute break in the chamber without the mask (oxygen concentration up to 23%, constant temperature (room) and humidity), again 20 minutes inhalation of 100% oxygen, another 5-minute break (the same condition), the last 20 minutes inhalation of 100% oxygen, and finally a 10-minute decompression. The total duration of the session was 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Hyperbaric oxygen (HBO) therapy. Receives: Procedure: Hyperbaric Oxygen Therapy |
| Controls | No intervention | Healthy individuals that never treated with HBO therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiobarbituric acid reactive substances (TBARS)
Lipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.
Measured: Three days, three different condition measurements
Malondialdehyde (MDA)
Lipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.
Measured: Three days, three different condition measurements
Conjugated dienes (CD)
Lipid peroxidation index, determined in plasma and erythrocytes.
Measured: Three days, three different condition measurements
Catalase (CAT)
Antioxidant enzyme, determined in erythrocytes.
Measured: Three days, three different condition measurements
Superoxide dismutase (SOD)
Antioxidant enzyme, determined in erythrocytes.
Measured: Three days, three different condition measurements
Glutathione peroxidase (GPx)
Antioxidant enzyme, determined in erythrocytes.
Measured: Three days, three different condition measurements
Secondary outcomes (12)
White blood cell count (WBC)
Leukocytes found in peripheral blood with specyfication of their types: lymphocytes, monocytes, neutrophils, eosinophils, basophils.
Measured: Two days, two different condition measurements
Red blood cell count (RBS)
Erythrocytes found in peripheral blood.
Measured: Two days, two different condition measurements
Hemoglobin (HGB)
Mean concentration of hemoglobin in the blood.
Measured: Two days, two different condition measurements
Hematocrit (HCT)
The percentage of red blood cells in the blood.
Measured: Two days, two different condition measurements
Mean corpuscular volume (MCV)
Mean volume of erythrocytes in the blood.
Measured: Two days, two different condition measurements
Mean corpuscular hemoglobin (MCH)
Mean mass of hemoglobin in an erythrocyte.
Measured: Two days, two different condition measurements
Mean corpuscular hemoglobin concentration (MCHC)
MCH expressed in a unit of blood volume.
Measured: Two days, two different condition measurements
Red cell distribution width (RDW)
Differences in the volume and size of erythrocytes.
Measured: Two days, two different condition measurements
Platelets (PLT)
Thrombocytes found in peripheral blood.
Measured: Two days, two different condition measurements
Plateletcrit (PCT)
Volume occupied by platelets in the blood.
Measured: Two days, two different condition measurements
Mean platelet volume (MPV)
Mean volume of thrombocytes in the blood.
Measured: Two days, two different condition measurements
Platelet distribution width (PDW)
Measurement of platelet anisocytosis calculated from the distribution of individual platelet volumes.
Measured: Two days, two different condition measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start26 Apr 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperbaric OxygenationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Sutkowy, Nicolaus Copernicus University
- Investigators
- Paweł Sutkowy, PhD, Principal investigator, Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401941
- Sponsor's protocol ID
- KB 260/2016
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no individual participant data (IPD) sharing plan.
Publications
Sutkowy P, Paprocki J, Piechocki J, Wozniak A. The impact of hyperbaric oxygen therapy on the redox balance of patients with diabetic foot syndrome. Free Radic Res. 2024 Nov;58(11):723-732. doi: 10.1080/10715762.2024.2417286. Epub 2024 Oct 19.
PubMed 39425927
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Staying in Hyperbaric Oxygen Conditions on the Oxidant-antioxidant Balance and the Activities of Selected Lysosomal Enzymes
- ClinicalTrials.gov ID
- NCT06401941
- Acronym / sponsor ID
- KB 260/2016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 May 2024 (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.
The aim of the research project was to investigate the effects of hyperbaric oxygen (HBO) treatment on the redox equilibrium in individuals with different pathological conditions. Both hyperbaric oxygenation and the pathological condition are associated with redox imbalance (oxidative stress), however, HBO is successfully used in the treatment of chronic wounds, e.g., diabetic foot syndrome, as well as in sudden and acute hearing loss, e.g., acute acoustic trauma or idiopathic sudden sensorineural hearing loss.
Detailed description
The study involed in sudden sensorineural hearing loss (SSNHL) patients, individuals with difficult-to-heal skin wounds following mechanical injuries, and diabetic foot patients. HBO therapy, which involved inhalation of 100% oxygen at a pressure of 2.5 atm, consisted of 14-30 sessions depending on the clinical case. The study material was venous blood drawn three times: before and after the first session, and after the last HBO procedure. The following variables were evaluated: the concentrations of thiobarbituric acid reactive substances (TBARS), malondialdehyde (MDA) and conjugated dienes (CD) in plasma and erythrocytes, the activities of catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidase (GPx) in erythrocytes, as well as, blood counts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Hyperbaric Oxygen TherapyHyperbaric oxygen (HBO) therapy. |
| Controls | No intervention | –Healthy individuals that never treated with HBO therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed informed consent form for participation in the study
Key exclusion criteria (3 listed)
- other pathological conditions (disorders, wounds, diseases)
- bad feeling of the participant on the day of the study,
- refraining from smoking, drinking alcohol, and the consumption of any dietary supplements that can affect the oxidant-antioxidant balance.
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 |
|---|---|---|
| Hyperbaric Oxygen TherapyAlso: HBO treatment, Hyperbaric OxygenationHBO session includes three 20-minute inhalations of pure oxygen in a hyperbaric chamber utilizing specially fitted face masks for each patient. The session is conducted as follows: 10 minutes compression of up to 2.5 atm (0.25 MPa), inhalation of 100% oxygen for 20 minutes, a 5-minute break in the chamber without the mask (oxygen concentration up to 23%, constant temperature (room) and humidity), again 20 minutes inhalation of 100% oxygen, another 5-minute break (the same condition), the last 20 minutes inhalation of 100% oxygen, and finally a 10-minute decompression. The total duration of the session was 90 minutes. | Procedure or surgery | Patients |
Primary outcome
Thiobarbituric acid reactive substances (TBARS)
Time frame: Three days, three different condition measurements
Lipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.
Malondialdehyde (MDA)
Time frame: Three days, three different condition measurements
Lipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.
Conjugated dienes (CD)
Time frame: Three days, three different condition measurements
Lipid peroxidation index, determined in plasma and erythrocytes.
Catalase (CAT)
Time frame: Three days, three different condition measurements
Antioxidant enzyme, determined in erythrocytes.
Superoxide dismutase (SOD)
Time frame: Three days, three different condition measurements
Antioxidant enzyme, determined in erythrocytes.
Glutathione peroxidase (GPx)
Time frame: Three days, three different condition measurements
Antioxidant enzyme, determined in erythrocytes.
12 secondary outcomes
White blood cell count (WBC)
Time frame: Two days, two different condition measurements
Red blood cell count (RBS)
Time frame: Two days, two different condition measurements
Hemoglobin (HGB)
Time frame: Two days, two different condition measurements
Hematocrit (HCT)
Time frame: Two days, two different condition measurements
Mean corpuscular volume (MCV)
Time frame: Two days, two different condition measurements
Mean corpuscular hemoglobin (MCH)
Time frame: Two days, two different condition measurements
Mean corpuscular hemoglobin concentration (MCHC)
Time frame: Two days, two different condition measurements
Red cell distribution width (RDW)
Time frame: Two days, two different condition measurements
Platelets (PLT)
Time frame: Two days, two different condition measurements
Plateletcrit (PCT)
Time frame: Two days, two different condition measurements
Mean platelet volume (MPV)
Time frame: Two days, two different condition measurements
Platelet distribution width (PDW)
Time frame: Two days, two different condition measurements
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 7 May 2024.
- Derived from this study: PubMed 39425927Sutkowy P, Paprocki J, Piechocki J, Wozniak A. The impact of hyperbaric oxygen therapy on the redox balance of patients with diabetic foot syndrome. Free Radic Res. 2024 Nov;58(11):723-732. doi: 10.1080/10715762.2024.2417286. Epub 2024 Oct 19.
- Individual participant dataSharing planned: No. There is no individual participant data (IPD) sharing plan.
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Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
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Recruiting
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Recruiting
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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.
Paweł Sutkowy, PhD principal investigator
Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Hyperbaric Oxygenation and Oxygen Toxicity, run by Nicolaus Copernicus University at 1 site in Poland.
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 1 inclusion and 3 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 7 May 2024. 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 Poland. 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?
Thiobarbituric acid reactive substances (TBARS) (time frame: Three days, three different condition measurements). The study lists 6 primary outcomes in all. 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 NCT06401941, which also lists 1 linked publication.
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 7 May 2024.