Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:22 AM
Study NCT ID:
NCT07361861
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Whether Hyperbaric Oxygen Therapy Can Improve VO₂-Max and Reduce Inflammation Markers in Healthy Adults Ages 30-60.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-15', 'size': 94654, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-15T18:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine levels', 'timeFrame': 'From enrollment to 4 weeks after the end of treatment (12 weeks after first treatment).', 'description': 'Cytokines will be measured via blood analysis. Samples will be taken before treatment, at the midpoint, at the end, and 4 weeks post treatment. This is a measure of inflammation in the body.'}, {'measure': 'VO2 max testing', 'timeFrame': 'From enrollment to 4 weeks post treatment (12 weeks after first treatment)', 'description': 'A treadmill VO2 max test measured before treatment, at treatment midpoint, at the end of treatment, and 4 weeks after conclusion of treatment. This is an indicator of cardiovascular health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiovascular Fitness', 'Inflammation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether hyperbaric oxygen therapy (HBOT) at 1.75 atmospheres of pressure (ATA) improves cardiovascular fitness (VO₂ max) and reduces inflammation in healthy adults. HBOT involves breathing pure oxygen in a pressurized chamber and is considered investigational for this use.\n\nRecent research has shown that different HBOT pressures can have different effects on inflammation. Specifically, some inflammatory cytokines (measurable markers of inflammation in the body) appear to decrease at low pressures like 1.3 ATA, while a different set of cytokines responds better at higher pressures, such as 2.0 ATA.\n\nCytokines are small proteins that play a crucial role in cell signaling, particularly within the immune system. They help regulate inflammation, infection response, and overall immune function. While some cytokines promote inflammation to fight off threats, others help reduce inflammation when it's no longer needed. An imbalance in cytokines - especially excessive inflammatory cytokines - can contribute to chronic inflammation, cardiovascular disease, and other health issues.\n\nIn this study, we are testing an intermediate pressure - 1.75 ATA - to see if we can target both sets of cytokines at once. If successful, this approach could offer broader anti-inflammatory benefits.\n\nWe are also interested in how this intermediate pressure may improve VO₂ max, a key indicator of cardiovascular fitness. Since VO₂ max is strongly linked to heart health and overall longevity, finding a safe and effective way to improve it has meaningful implications not just for athletes, but for anyone looking to enhance their fitness and well-being."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically active individuals with no history of chronic illness or HBOT exposure within the last three months.\n\nExclusion Criteria:\n\n* individuals with contraindications to HBOT, including lung diseases or claustrophobia.'}, 'identificationModule': {'nctId': 'NCT07361861', 'briefTitle': 'Evaluating Whether Hyperbaric Oxygen Therapy Can Improve VO₂-Max and Reduce Inflammation Markers in Healthy Adults Ages 30-60.', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'The Effects of Hyperbaric Oxygen Therapy at Intermediate Pressure (1.75 ATA) on VO₂ Max and Inflammatory Cytokine Profiles', 'orgStudyIdInfo': {'id': 'STUDY00007903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric Oxygen Therapy 1.75 atmospheres', 'description': 'Will complete 24 HBOT sessions, each lasting 100 minutes, over 8 weeks.', 'interventionNames': ['Device: Hyperbaric Oxygen Therapy']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy', 'type': 'DEVICE', 'description': '24 Hyperbaric Oxygen Therapy, each lasting 100 minutes, 3 times a week for 8 weeks.', 'armGroupLabels': ['Hyperbaric Oxygen Therapy 1.75 atmospheres']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Lehrer', 'role': 'CONTACT'}], 'facility': 'ATX Hyperbarics', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Westlake Medical Arts', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Emma Lehrer, BSA Biology', 'role': 'CONTACT', 'email': 'elehrer@utexas.edu', 'phone': '7379321934'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John Powers', 'investigatorAffiliation': 'University of Texas at Austin'}}}}