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

• Sponsor: TruDiagnostic (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05297019
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Procedure: Hyperbaric Oxygen Therapy	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The "control" group will crossover to active treatment after 3 months of observation.The "control" group will crossover to active treatment after 3 months of observation.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Participants, the principal investigator, and outcomes assessor will be blinded to patient's HBOT dosing. Technicians at the clinic will know which treatment dose each participant is receiving in order to deliver appropriate dosing.
• Primary Purpose: Health Services Research
• Official Title: Hyperbaric Dosage Analysis Effect Of Various PO2 Exposures: Hyperoxia-Hypoxia Paradox On Stem Cell Mobilization, Cell Signaling, Inflammation, Epigenetics & Cell Regeneration
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Epigenetic Aging [Testing will compare baseline with 6 months]

   DNA methylation of blood samples for epigenetic age

Secondary Outcome Measures

1. Neurotrax [Testing will compare baseline with 6 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Jersey HBOT	Florham Park	New Jersey	United States	07932

Sponsors and Collaborators

• TruDiagnostic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TruDiagnostic
• ClinicalTrials.gov Identifier: NCT05297019
• Other Study ID Numbers: SM-TD-001
• First Posted: Mar 25, 2022
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 25, 2022