- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07361861
Evaluating Whether Hyperbaric Oxygen Therapy Can Improve VO₂-Max and Reduce Inflammation Markers in Healthy Adults Ages 30-60.
The Effects of Hyperbaric Oxygen Therapy at Intermediate Pressure (1.75 ATA) on VO₂ Max and Inflammatory Cytokine Profiles
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.
Recent 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.
Cytokines 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.
In 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.
We 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emma Lehrer, BSA Biology
- Phone Number: 7379321934
- Email: elehrer@utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78746
- Recruiting
- ATX Hyperbarics
-
Contact:
- Emma Lehrer
-
Austin, Texas, United States, 78746
- Active, not recruiting
- Westlake Medical Arts
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- physically active individuals with no history of chronic illness or HBOT exposure within the last three months.
Exclusion Criteria:
- individuals with contraindications to HBOT, including lung diseases or claustrophobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyperbaric Oxygen Therapy 1.75 atmospheres
Will complete 24 HBOT sessions, each lasting 100 minutes, over 8 weeks.
|
24 Hyperbaric Oxygen Therapy, each lasting 100 minutes, 3 times a week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cytokine levels
Time Frame: From enrollment to 4 weeks after the end of treatment (12 weeks after first treatment).
|
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.
|
From enrollment to 4 weeks after the end of treatment (12 weeks after first treatment).
|
|
VO2 max testing
Time Frame: From enrollment to 4 weeks post treatment (12 weeks after first treatment)
|
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.
|
From enrollment to 4 weeks post treatment (12 weeks after first treatment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007903
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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