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Completed

NCT Number: NCT06401941

Selected Lysosomal Enzyme Activities and the Oxidant-antioxidant Balance in Hyperbaric Oxygen Condition.

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.

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Key information

Conditions

Hyperbaric Oxygenation Antioxidants Oxidative Stress Oxygen Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent form for participation in the study

Exclusion criteria

  • 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.

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

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.

Other names: HBO treatment, Hyperbaric Oxygenation

Primary outcomes

  1. 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.

  2. 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.

  3. Conjugated dienes (CD)

    Time frame: Three days, three different condition measurements

    Lipid peroxidation index, determined in plasma and erythrocytes.

  4. Catalase (CAT)

    Time frame: Three days, three different condition measurements

    Antioxidant enzyme, determined in erythrocytes.

  5. Superoxide dismutase (SOD)

    Time frame: Three days, three different condition measurements

    Antioxidant enzyme, determined in erythrocytes.

  6. Glutathione peroxidase (GPx)

    Time frame: Three days, three different condition measurements

    Antioxidant enzyme, determined in erythrocytes.

Secondary outcomes

  1. White blood cell count (WBC)

    Time frame: Two days, two different condition measurements

    Leukocytes found in peripheral blood with specyfication of their types: lymphocytes, monocytes, neutrophils, eosinophils, basophils.

  2. Red blood cell count (RBS)

    Time frame: Two days, two different condition measurements

    Erythrocytes found in peripheral blood.

  3. Hemoglobin (HGB)

    Time frame: Two days, two different condition measurements

    Mean concentration of hemoglobin in the blood.

  4. Hematocrit (HCT)

    Time frame: Two days, two different condition measurements

    The percentage of red blood cells in the blood.

  5. Mean corpuscular volume (MCV)

    Time frame: Two days, two different condition measurements

    Mean volume of erythrocytes in the blood.

  6. Mean corpuscular hemoglobin (MCH)

    Time frame: Two days, two different condition measurements

    Mean mass of hemoglobin in an erythrocyte.

  7. Mean corpuscular hemoglobin concentration (MCHC)

    Time frame: Two days, two different condition measurements

    MCH expressed in a unit of blood volume.

  8. Red cell distribution width (RDW)

    Time frame: Two days, two different condition measurements

    Differences in the volume and size of erythrocytes.

  9. Platelets (PLT)

    Time frame: Two days, two different condition measurements

    Thrombocytes found in peripheral blood.

  10. Plateletcrit (PCT)

    Time frame: Two days, two different condition measurements

    Volume occupied by platelets in the blood.

  11. Mean platelet volume (MPV)

    Time frame: Two days, two different condition measurements

    Mean volume of thrombocytes in the blood.

  12. Platelet distribution width (PDW)

    Time frame: Two days, two different condition measurements

    Measurement of platelet anisocytosis calculated from the distribution of individual platelet volumes.

Sponsors and collaborators

Lead sponsor

Nicolaus Copernicus University

Other

Registry information

Official study title

The Impact of Staying in Hyperbaric Oxygen Conditions on the Oxidant-antioxidant Balance and the Activities of Selected Lysosomal Enzymes

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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