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This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Mild pressure HBOT | Experimental | "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 |
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| Arm 2: High pressure HBOT | Experimental | "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 |
|
| Arm 3: Crossover Arm | Experimental | Patients will have 3 months of no treatment, and then be randomized to receive either high pressure or mild pressure HBOT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Procedure | hyperbaric oxygen therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Epigenetic Aging | DNA methylation of blood samples for epigenetic age | Testing will compare baseline with 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey HBOT | Florham Park | New Jersey | 07932 | United States |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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The "control" group will crossover to active treatment after 3 months of observation.
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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.