AgingPhase 2/3HBOTNCT05297019
A Dosing Study of Hyperbaric Oxygen Therapy (HBOT) on Epigenetic Aging
A Phase 2/3 study testing Hyperbaric Oxygen Therapy in people with Aging, run by TruDiagnostic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Jul 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- Hyperbaric Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
hyperbaric oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Aging
DNA methylation of blood samples for epigenetic age
Measured: Testing will compare baseline with 6 months
Secondary outcomes (1)
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
Measured: Testing will compare baseline with 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The "control" group will crossover to active treatment after 3 months of observation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297019
- Sponsor's protocol ID
- SM-TD-001
- Acronym
- HBOT
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Dosage Analysis Effect Of Various PO2 Exposures: Hyperoxia-Hypoxia Paradox On Stem Cell Mobilization, Cell Signaling, Inflammation, Epigenetics & Cell Regeneration
- ClinicalTrials.gov ID
- NCT05297019
- Acronym / sponsor ID
- HBOT / SM-TD-001
- Conditions
- Aging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The "control" group will crossover to active treatment after 3 months of observation.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Mild pressure HBOT | Experimental | Procedure: Hyperbaric Oxygen Therapy"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 |
| Arm 2: High pressure HBOT | Experimental | Procedure: Hyperbaric Oxygen Therapy"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 | Procedure: Hyperbaric Oxygen TherapyPatients will have 3 months of no treatment, and then be randomized to receive either high pressure or mild pressure HBOT |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapyhyperbaric oxygen therapy | Procedure or surgery | Arm 1: Mild pressure HBOT, Arm 2: High pressure HBOT, Arm 3: Crossover Arm |
Primary outcome
Epigenetic Aging
Time frame: Testing will compare baseline with 6 months
DNA methylation of blood samples for epigenetic age
1 secondary outcome
Neurotrax
Time frame: Testing will compare baseline with 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyperbaric Oxygen Therapy in people with Aging, run by TruDiagnostic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Aging (time frame: Testing will compare baseline with 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.