NCT07361861

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

Study Start

First participant enrolled

January 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Cardiovascular FitnessInflammation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to 4 weeks post treatment (12 weeks after first treatment)

Study Arms (1)

Hyperbaric Oxygen Therapy 1.75 atmospheres

EXPERIMENTAL

Will complete 24 HBOT sessions, each lasting 100 minutes, over 8 weeks.

Device: Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen TherapyDEVICE

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

Hyperbaric Oxygen Therapy 1.75 atmospheres

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • physically active individuals with no history of chronic illness or HBOT exposure within the last three months.

You may not qualify if:

  • individuals with contraindications to HBOT, including lung diseases or claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ATX Hyperbarics

Austin, Texas, 78746, United States

RECRUITING

Westlake Medical Arts

Austin, Texas, 78746, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Central Study Contacts

Emma Lehrer, BSA Biology

CONTACT

7379321934elehrer@utexas.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(2)