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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05297019
Other study ID # SM-TD-001
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 1, 2022
Est. completion date July 1, 2023

Study information

Verified date April 2023
Source TruDiagnostic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date July 1, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hyperbaric Oxygen Therapy
hyperbaric oxygen therapy

Locations

Country Name City State
United States New Jersey HBOT Florham Park New Jersey

Sponsors (1)

Lead Sponsor Collaborator
TruDiagnostic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epigenetic Aging DNA methylation of blood samples for epigenetic age Testing will compare baseline with 6 months
Secondary 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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