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

TruDiagnostic

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Aging

Treatments: Procedure: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05297019

SM-TD-001

Details and patient eligibility

About

This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.

Full description

While current research has identified many mechanisms of action, effects and cell signaling benefits resulting from HBOT, we do not have a firm understanding of the timeframe and dosage for many of these expected adaptations. Data from this study will be collected and shared on an ongoing basis throughout the course of care. This research project will help us to confirm these cell-signaling changes and benefits, and also develop a better understanding of the necessary PO2 and time frame required in order to achieve these changes leading to improved patient outcomes in the field of hyperbaric medicine.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Any sex, gender orientation, and ethnicity
2. Between ages 40 and 70
3. Must be willing and able to participate in venipuncture, health history and clinical assessments, lab test assessment, hyperbaric oxygen treatment.
4. 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.

Exclusion criteria

1. 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
2. Any ongoing immune system concerns or immunodeficiency disease
3. Body mass index (BMI) changes of more than 5% over the course of the study
4. Changes in weight of more than 15 lbs. during the course of the study
5. Presence of a severe active infection as determined by the principal investigator.
6. Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable
7. Unable or unwilling to provide required biological sample
8. Unable or unwilling to avoid pregnancy during study period
9. Presence of cataracts before the study begins
10. Myopic changes within the first 30 days of treatment

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Arm 1: Mild pressure HBOT

Experimental group

Description:

"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

Treatment:

Procedure: Hyperbaric Oxygen Therapy

Arm 2: High pressure HBOT

Experimental group

Description:

"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

Treatment:

Procedure: Hyperbaric Oxygen Therapy

Arm 3: Crossover Arm

Experimental group

Description:

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

Treatment:

Procedure: Hyperbaric Oxygen Therapy