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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Procedure: Hyperbaric Oxygen Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Annie Prestrud; Phone Number: 6102208921; Email: annie@trudiagnostic.com

Study Locations

• United States
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • New Jersey HBOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Mild pressure HBOT; "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; hyperbaric oxygen therapy
Experimental: Arm 2: High pressure HBOT; "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; hyperbaric oxygen therapy
Experimental: Arm 3: Crossover Arm; 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; hyperbaric oxygen therapy

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

Collaborators and Investigators

• Sponsor: TruDiagnostic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SM-TD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No