Hyperbaric Oxygen Therapy for 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how hyperbaric oxygen therapy (HBOT) might affect aging at a genetic level, as well as inflammation and overall cell health. Participants will receive either mild or high-pressure oxygen treatments, or initially receive no treatment before being assigned to one of these groups. Ideal candidates are those between 40 and 70 years old who can maintain their current lifestyle habits and are comfortable with medical procedures like blood tests. This study could reveal new ways to slow aging and improve health.

As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to groundbreaking advancements in health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally safe for most people. In past studies, most side effects were mild and short-lived, with serious issues being rare. Breathing pure oxygen at a lower pressure is usually safe, while problems are more likely when the pressure exceeds 2.0 ATA (a unit of pressure).

Even at higher pressures, HBOT remains one of the safer treatments. However, individuals with an untreated pneumothorax (a collapsed lung) should not undergo HBOT. Overall, both mild and high-pressure HBOT have been well-tolerated in research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Hyperbaric Oxygen Therapy (HBOT) for its potential to impact epigenetic aging in a way that traditional treatments cannot. Unlike standard aging treatments that might focus on lifestyle changes or medications to manage symptoms, HBOT delivers 100% oxygen at increased pressures, which may trigger beneficial genetic changes. The study explores both mild and high-pressure versions of HBOT, offering a unique approach by potentially reversing biological aging markers rather than just slowing them down. This could pave the way for a novel method to promote healthier aging at the cellular level.

What evidence suggests that hyperbaric oxygen therapy could be effective for epigenetic aging, inflammation, and cellular health?

Research has shown that hyperbaric oxygen therapy (HBOT) can deliver more oxygen throughout the body by using pure oxygen at higher air pressure. This extra oxygen can trigger processes that repair tissues and reduce swelling. In this trial, participants will be assigned to different treatment arms to evaluate the effects of varying HBOT pressures. Studies on low-pressure HBOT, which participants in Arm 1 may receive, suggest it can offer benefits with fewer side effects compared to higher pressures. In contrast, high-pressure HBOT, which participants in Arm 2 may receive, has proven effective in speeding up wound healing by providing tissues with more oxygen. Both low and high-pressure HBOT increase oxygen levels in the blood and tissues, potentially supporting better cell health and reducing signs of aging. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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) 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]

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]

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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8465921/

A General Overview on the Hyperbaric Oxygen Therapy Hyperbaric oxygen therapy (HBOT) is a therapeutical approach based on exposure to pure concentrations of oxygen (O2) in an augmented atmospheric pressure.

2. mayoclinic.org mayoclinic.org/tests-procedures/hyperbaric-oxygen-therapy/about/pac-20394380

Hyperbaric oxygen therapy Hyperbaric oxygen therapy increases delivery of oxygen to the body by providing pure oxygen in an enclosed space with higher than normal air pressure.

3. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/hyperbaric-oxygen-therapy

Hyperbaric Oxygen Therapy HBOT reduces swelling while flooding the tissues with oxygen. The higher pressure in the chamber increases the amount of oxygen in the blood. HBOT aims to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825000841

Efficacy of hyperbaric oxygen therapy combine with ... Combining NPWT and HBOT significantly improves the rate of wound healing compared to NPWT alone in chronic wounds, with no significant differences in pain or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06118138

Hyperbaric High Pressure Oxygen Therapy in Post-COVID ... The objective of this observational study is to document symptom progression in 60 patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5467109/

Hyperbaric Oxygen Therapy: Side Effects Defined and ... HBOT remains among the safest therapies used today. Nonetheless, there are side effects associated with HBOT.

7. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/complications-of-hyperbaric-oxygen-treatment

Complications of Hyperbaric Oxygen Treatment You breathe pure oxygen inside a highly pressurized chamber during hyperbaric oxygen therapy (HBOT). Often, pressure is between 1.5 and 3 times greater than ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557661/

Hyperbaric Oxygen Therapy Contraindications - NCBI - NIH The only absolute contraindication to HBOT is an untreated pneumothorax. Placing a patient in a chamber and altering ambient pressure can precipitate a life- ...

9. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1160774/full

Adverse effects of hyperbaric oxygen therapy: a systematic ... While the chamber pressure is lower than 2.0 ATA, HBOT is relatively safe compared with the previous one. Conclusion: Hyperbaric oxygen therapy ...