Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 12:36 PM
Study NCT ID:
NCT06284603
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Hyperbaric Oxygen Therapy in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two study groups (dependent on frequency of HBOT treatments) and control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of oxygen and carbon dioxide', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'A cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a portable breath-by-breath ergospirometer; VO2 and VCO2 are measured constantly.'}, {'measure': 'Heart rate', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'Cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a heart rate monitor.'}, {'measure': 'Vascular circulation measures', 'timeFrame': 'baseline (before and immediately after CPET), before and after 5th treatment, and the next morning after the last HBOT intervention (before and immediately after CPET); up to 24 days.', 'description': 'Nicotinamide adenine dinucleotide (NADH) content changes in the skin area are measured during transient ischemia and reperfusion with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland)'}], 'secondaryOutcomes': [{'measure': 'Body composition (body mass, fat mass, lean body mass, muscle mass)', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'Body composition is tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA).'}, {'measure': 'Inflammatory cytokine profile', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'tumor necrosis factor (TNFalfa) and interleukins (IL-1beta, IL-6, IL-10) is measured using immunoenzymatic methods'}, {'measure': 'Oxidative stress indicators', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'The activity of superoxide dismutase (SOD); catalase (CAT); glutathione peroxidase (GPx) is measured using spectrophotometric and immunoenzymatic methods'}, {'measure': 'F2-Isoprostanes (F2-IsoP)', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'The measurement of F2-Isoprostanes (F2-IsoP) is performed using the spectrophotometric and immunoenzymatic methods'}, {'measure': 'Brain-derived neurotrophic factor concentration (BDNF)', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'BDNF concentration is measured using immunoenzymatic methods'}, {'measure': 'Nicotinamide (NAD) metabolites', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'NAD metabolites are measured using a combination of high-performance liquid chromatography-mass spectrometer methods (HPLC-MS)'}, {'measure': 'Gut microbiome and metabolome', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'Metabolites produced by bacteria such as short-chain fatty acids (SCFA), tryptophan catabolites, and non-targeted metabolomes are measured using Ultra High Pressure Liquid Chromatography (UHPLC)'}, {'measure': 'Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA)', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'Indicators of intestinal inflammation are measured using Western blot analysis and real-time Polymerase Chain Reaction (RT-PCR).'}, {'measure': 'endothelial nitric oxide synthase (eNOS)', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'eNOS activity is measured using immunoenzymatic methods'}, {'measure': 'Vascular endothelial growth factor (VEGF)', 'timeFrame': 'baseline and after the intervention; up to 24 days.', 'description': 'Concentration of VEGF is measured using immunoenzymatic methods'}, {'measure': 'Hypoxia inducible factor-1 (HIF-1alfa)', 'timeFrame': 'baseline and the next morning after the last HBOT intervention; up to 24 days.', 'description': 'Concentration of HIF-1alfa is measured using immunoenzymatic methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical performance', 'vascular circulation', 'gut microbiota'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.\n\nThe main questions it aims to answer are:\n\n1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?\n2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?\n3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?\n\nParticipants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-35;\n* Healthy, physically active men;\n* Subject who is knowingly willing to participate in the study;\n* Subject able to read, understand and sign an informed consent to participate.\n\nExclusion Criteria:\n\n* Inability to attend scheduled visits and/or follow study protocol;\n* Use of HBOT prior to study inclusion;\n* Severe or unstable physical impairment or severe cognitive deficits at study entry;\n* Pressure-sensitive chest diseases (including moderate or severe asthma) or pressure-sensitive ear or sinus diseases;\n* Active smoking;\n* Having suffered an injury within 3 months up to the date of the study;\n* Taking pre- and/or probiotics in the last 3 months before the study;\n* Inpatient hospital or emergency room stay in the last 4 weeks prior to study entry;\n* Travel to tropical countries during the last 4 weeks prior to the study;\n* Taking antibiotics, steroids and steroid-anabolic agents during the last 4 weeks before the study'}, 'identificationModule': {'nctId': 'NCT06284603', 'briefTitle': 'Effectiveness of Hyperbaric Oxygen Therapy in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'The Effects of Hyperbaric Oxygen Therapy on Physical Capacity, Health, and Gut Microbiota in Healthy Male Adults', 'orgStudyIdInfo': {'id': 'AWF_LA_HBOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group 1: HBOT 3/week', 'description': 'The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week.', 'interventionNames': ['Device: Hyperbaric Oxygen Therapy - HBOT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group 2: HBOT 6/week', 'description': 'The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week.', 'interventionNames': ['Device: Hyperbaric Oxygen Therapy - HBOT']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No changes to a daily routine.'}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy - HBOT', 'type': 'DEVICE', 'description': 'Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes', 'armGroupLabels': ['Study Group 1: HBOT 3/week', 'Study Group 2: HBOT 6/week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-871', 'city': 'Poznan', 'state': 'Wielkopolska', 'country': 'Poland', 'facility': 'Poznan University of Physical Education', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Barbara Pospieszna, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poznan, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}