A Dosing Study of Hyperbaric Oxygen Therapy (HBOT) on Epigenetic Aging

(HBOT Trial)

Overseen By Annie Prestrud

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: TruDiagnostic

Disqualifiers: Diabetes, Cancer, Cardiovascular, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying how breathing pure oxygen in a pressurized chamber can improve cell health, reduce inflammation, and slow aging. The goal is to find the best oxygen levels and treatment durations for these benefits. The therapy involves breathing oxygen in a pressurized environment and is associated with anti-inflammatory, antioxidant, and healing properties.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must maintain your current lifestyle choices, so it's best to discuss your medications with the study staff.

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy (HBOT)?

Research suggests that Hyperbaric Oxygen Therapy (HBOT) may help patients with carbon monoxide poisoning and thermal burns by increasing the oxygen supply to the body, although its effects on wound healing and traumatic brain injury are still unclear. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy generally safe for humans?

Hyperbaric oxygen therapy is generally considered safe, but it can have side effects like ear or sinus pain, anxiety, low blood sugar, oxygen toxicity (too much oxygen in the body), and changes in vision. Serious side effects are rare, but they can include seizures and lung problems. ^{6 7 8 9 10}

How is hyperbaric oxygen therapy different from other treatments?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized chamber, which is different from most treatments that do not use increased pressure or 100% oxygen. This method can enhance healing by increasing oxygen delivery to tissues, which is particularly beneficial for conditions like burns and fractures that require improved blood flow and oxygenation. ^{3 11 12 13 14}

Eligibility Criteria

Inclusion Criteria

Participants must also agree to maintain their current lifestyle choices consistent with pre- participation with this study. Participants should not change their exercise programs, diets, sleep patterns supplements or other. Any significant changes in their lifestyle choices must be reported to the staff.

People of any gender, sexual orientation, and ethnicity are eligible to participate.

Between ages 40 and 70

Exclusion Criteria

Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition

Presence of a severe active infection as determined by the principal investigator.

Unable or unwilling to provide required biological sample

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mild or high pressure HBOT: 100% O2 for 100 minutes 3x/week for 6 weeks, followed by 2 weeks off, and then an additional 4 weeks of therapy

12 weeks

No Treatment Period

Participants undergo a period of no treatment to assess long-term effects

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of epigenetic aging and brain fitness

6 months

Treatment Details

Interventions

• Hyperbaric Oxygen Therapy

Participant Groups

Group I: Arm 3: Crossover Arm Experimental Treatment 1 Intervention

Patients will have 3 months of no treatment, and then be randomized to receive either high pressure or mild pressure HBOT

Group II: Arm 2: High pressure HBOT Experimental Treatment 1 Intervention

"High" pressure HBOT: 100% O2 @ 14 PSI for 100 minutes 3x/week for 6 weeks, 2 weeks off, and then an additional 4 weeks of therapy. Followed by 3 months of no treatment

Group III: Arm 1: Mild pressure HBOT Experimental Treatment 1 Intervention

"Mild" pressure HBOT: 100% O2 @ 4.2 PSI for 100 minutes 3x/week for 6 weeks, 2 weeks off, and then an additional 4 weeks of therapy. Followed by 3 months of no treatment

Hyperbaric Oxygen Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in European Union as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury
• Diabetic foot ulcers

Approved in Canada as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in Japan as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing

Who Is Running the Clinical Trial?

TruDiagnostic

Lead Sponsor

Trials

12

Recruited

490+

Founded

2019

Headquarters

Lexington, United States

Known For

Epigenetic testing

Findings from Research

Hyperbaric oxygen therapy (HBOT) did not significantly reduce in-hospital mortality in patients with carbon monoxide poisoning, with rates of 0.8% in the HBOT group compared to 1.2% in the control group.

However, patients receiving HBOT showed improved mental status and activities of daily living at discharge, indicating potential benefits for recovery, especially in those with non-severe poisoning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy and mortality from carbon monoxide poisoning: A nationwide observational study. Nakajima, M., Aso, S., Matsui, H., et al.[2020]

A systematic review of two randomized controlled trials on hyperbaric oxygen therapy (HBOT) for thermal burns found insufficient evidence to support its effectiveness, as the trials had poor methodological quality.

One trial indicated that HBOT may reduce healing times (19.7 days vs. 43.8 days), but the other showed no significant differences in length of hospital stay, mortality, or surgeries, highlighting the need for further research to clarify HBOT's role in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for thermal burns. Villanueva, E., Bennett, MH., Wasiak, J., et al.[2022]

Hyperbaric oxygen therapy (HBOT) may offer a potential mortality benefit for certain subgroups of traumatic brain injury (TBI) patients, as one study showed a decrease in mortality from 31% in controls to 17% in the HBOT group, although results were conflicting across studies.

Adverse events associated with HBOT, such as seizures and pulmonary symptoms, were reported, but the overall evidence regarding its effectiveness and safety remains insufficient, highlighting the need for more high-quality research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for traumatic brain injury: a systematic review of the evidence. McDonagh, M., Helfand, M., Carson, S., et al.[2019]

In a review of over 1.5 million hyperbaric oxygen therapy treatments, only 0.68% were linked to adverse events, indicating that serious complications are rare.

The most common issues reported were barotrauma and confinement anxiety, while severe events like oxygen toxicity occurred in less than 0.05 per 1000 treatments, suggesting that HBO therapy is a safe and low-risk treatment when following proper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. Jokinen-Gordon, H., Barry, RC., Watson, B., et al.[2022]

In a study of 2,334 patients undergoing hyperbaric oxygen (HBO2) therapy, 17.4% experienced adverse events, with the most common being middle ear barotrauma affecting 9.2% of patients.

Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 therapy is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. hadanny, A., Meir, O., Bechor, Y., et al.[2016]

Hyperbaric oxygen therapy (HBOT) is associated with a higher incidence of adverse effects (30.11%) compared to control groups (10.43%), particularly when the treatment involves more than 10 sessions or chamber pressures exceed 2.0 ATA.

The most common side effect reported was ear discomfort, indicating that while HBOT can be beneficial, careful monitoring for adverse reactions is necessary, especially under specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. Zhang, Y., Zhou, Y., Jia, Y., et al.[2023]

Hyperbaric oxygen therapy (HBOT) improves wound healing by enhancing oxygenation, promoting new blood vessel formation (neovascularization), and reducing inflammation, making it a valuable adjunctive treatment for chronic wounds and infections.

Clinical evidence supports the use of HBOT in various conditions, including diabetic ulcers and chronic osteomyelitis, and it may reduce the risk of severe outcomes like amputation, although many healthcare providers are still unfamiliar with its applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence. Lam, G., Fontaine, R., Ross, FL., et al.[2022]

A study of 155 patients undergoing hyperbaric oxygen (HBO₂) therapy revealed that there is a measurable increase in blood pressure (systolic, diastolic, and mean arterial pressure) following treatment, although the increase is not large.

Patients taking calcium channel blockers and beta-blockers experienced greater increases in blood pressure, while those on ACE inhibitors had a protective effect, suggesting that medication type can influence blood pressure responses during HBO₂ therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. Heyboer Rd, M., Wojcik, SM., Smith, G., et al.[2019]

This systematic review found no clinical trials that provided evidence for the effectiveness of hyperbaric oxygen therapy (HBOT) in treating delayed healing or established non-union of bony fractures, indicating a lack of supporting data.

The authors concluded that high-quality clinical trials are necessary to determine whether HBOT has any beneficial role in managing these types of bone injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Bennett, MH., Stanford, R., Turner, R.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Electroacupuncture on Transcutaneous Oxygen Partial Pressure During Hyperbaric Oxygen Therapy in Healthy Individuals. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy and mortality from carbon monoxide poisoning: A nationwide observational study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for thermal burns. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for traumatic brain injury: a systematic review of the evidence. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. [2019]

11. Australia pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in China. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. [2018]

13. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. [2021]