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

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

Detailed 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.

Official Title
-----------------
Hyperbaric Dosage Analysis Effect Of Various PO2 Exposures: Hyperoxia-Hypoxia Paradox On Stem Cell Mobilization, Cell Signaling, Inflammation, Epigenetics & Cell Regeneration

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Procedure: Hyperbaric Oxygen Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any sex, gender orientation, and ethnicity Between ages 40 and 70 Must be willing and able to participate in venipuncture, health history and clinical assessments, lab test assessment, hyperbaric oxygen treatment. 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: 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 Any ongoing immune system concerns or immunodeficiency disease Body mass index (BMI) changes of more than 5% over the course of the study Changes in weight of more than 15 lbs. during the course of the study Presence of a severe active infection as determined by the principal investigator. Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable Unable or unwilling to provide required biological sample Unable or unwilling to avoid pregnancy during study period Presence of cataracts before the study begins Myopic changes within the first 30 days of treatment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The control group will crossover to active treatment after 3 months of observation.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Mild pressure HBOT<br>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 | Procedure: Hyperbaric Oxygen Therapy<br>* hyperbaric oxygen therapy<br>|
| Experimental: Arm 2: High pressure HBOT<br>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 | Procedure: Hyperbaric Oxygen Therapy<br>* hyperbaric oxygen therapy<br>|
| Experimental: Arm 3: Crossover Arm<br>Patients will have 3 months of no treatment, and then be randomized to receive either high pressure or mild pressure HBOT | Procedure: Hyperbaric Oxygen Therapy<br>* hyperbaric oxygen therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic Aging | DNA methylation of blood samples for epigenetic age | Testing will compare baseline with 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurotrax | Brain Care brain fitness tests follow the neuropsychological tradition by measuring: Memory, Executive Function, Attention, Visual Spatial, Verbal Function, Problem Solving, Working Memory. These tests are performed on a computer through a secure online assessment procedure. The scores on these tests are aggregated to create on measure of brain fitness | Testing will compare baseline with 6 months |