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

NCT05297019 | Unknown Phase 2

• 1 other identifier: SM-TD-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Epigenetic Aging

  DNA methylation of blood samples for epigenetic age

  Testing will compare baseline with 6 months

Secondary Outcomes (1)

• Neurotrax

  Testing will compare baseline with 6 months

Study Arms (3)

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

Procedure: Hyperbaric Oxygen Therapy

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

Procedure: Hyperbaric Oxygen Therapy

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

Procedure: Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

hyperbaric oxygen therapy

Arm 1: Mild pressure HBOT; Arm 2: High pressure HBOT; Arm 3: Crossover Arm

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TruDiagnostic: lead

Study Sites (1)

New Jersey HBOT

Florham Park, New Jersey, 07932, United States

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The "control" group will crossover to active treatment after 3 months of observation.

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 25, 2022
• Study Start: March 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: July 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (1)