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Recruiting NCT07361861

Evaluating Whether Hyperbaric Oxygen Therapy Can Improve VO₂-Max and Reduce Inflammation Markers in Healthy Adults Ages 30-60.

No phase Interventional Cardiovascular Fitness Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric Oxygen Therapy.
Who it may be relevant to
Registry conditions: Cardiovascular Fitness, Inflammation. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of Hyperbaric Oxygen Therapy at Intermediate Pressure (1.75 ATA) on VO₂ Max and Inflammatory Cytokine Profiles

Overview

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.

Interventions

  • Device Hyperbaric Oxygen Therapy
    24 Hyperbaric Oxygen Therapy, each lasting 100 minutes, 3 times a week for 8 weeks.

Primary outcome measures

  • Cytokine levels [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • ATX Hyperbarics — Austin
  • Westlake Medical Arts — Austin

Identifiers

NCT: NCT07361861 · STUDY00007903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗