Cardiovascular FitnessNCT07361861
Evaluating Whether Hyperbaric Oxygen Therapy Can Improve VO₂-Max and Reduce Inflammation Markers in Healthy Adults Ages 30-60.
A study testing Hyperbaric Oxygen Therapy in people with Cardiovascular Fitness and Inflammation, run by University of Texas at Austin at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Fitness, Inflammation
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- physically active individuals with no history of chronic illness or HBOT exposure within the last three months.
Who cannot join
- individuals with contraindications to HBOT, including lung diseases or claustrophobia.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
ATX Hyperbarics
Austin, Texas, 78746
Emma Lehrer
- Active, not recruiting
Westlake Medical Arts
Austin, Texas, 78746
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiovascular Fitness, Inflammation
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
24 Hyperbaric Oxygen Therapy, each lasting 100 minutes, 3 times a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy 1.75 atmospheres | Experimental | Will complete 24 HBOT sessions, each lasting 100 minutes, over 8 weeks. Receives: Device: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels
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.
Measured: From enrollment to 4 weeks after the end of treatment (12 weeks after first treatment).
VO2 max testing
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.
Measured: From enrollment to 4 weeks post treatment (12 weeks after first treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular FitnessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Powers, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361861
- Sponsor's protocol ID
- STUDY00007903
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyperbaric Oxygen Therapy at Intermediate Pressure (1.75 ATA) on VO₂ Max and Inflammatory Cytokine Profiles
- ClinicalTrials.gov ID
- NCT07361861
- Acronym / sponsor ID
- STUDY00007903
- Conditions
- Cardiovascular Fitness, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Jan 2026 (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 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy 1.75 atmospheres | Experimental | Device: Hyperbaric Oxygen TherapyWill complete 24 HBOT sessions, each lasting 100 minutes, over 8 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- physically active individuals with no history of chronic illness or HBOT exposure within the last three months.
Key exclusion criteria (1 listed)
- individuals with contraindications to HBOT, including lung diseases or claustrophobia.
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 Therapy24 Hyperbaric Oxygen Therapy, each lasting 100 minutes, 3 times a week for 8 weeks. | Device | Hyperbaric Oxygen Therapy 1.75 atmospheres |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 Cardiovascular Fitness and Inflammation, run by University of Texas at Austin at 2 sites in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Lehrer, BSA Biology (7379321934, elehrer@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine levels (time frame: From enrollment to 4 weeks after the end of treatment (12 weeks after first treatment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.