Trials / Completed
CompletedNCT06665633
Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Nova Southeastern University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Mild traumatic brain (mTBI) injury affects 400,000 U.S. Veterans resulting in physical, cognitive and mental health symptoms. The Department of Defense (DoD) reported 26 suicides a day from mTBI despite ongoing care for the Veterans. The purpose of this pilot research study is to evaluate the effect of treating Veterans suffering from mTBI or persistent post-concussion syndrome with hyperbaric oxygen therapy (HBOT).
Detailed description
In 40 male U.S. Veterans, who have had chronic mTBI for at least six months, the effect of HBOT will be measured in this pilot study with online questionnaires before and after HBOT to measure mental health issues (e.g. depression) and brain function (e.g. memory). The questionnaires will be repeated at 6 and 12 months after HBOT. Brain SPECT (single-photon emission computerized tomography) scans, will measure blood flow to the brain's injured areas before and after HBOT. Quantitative Electroencephalography (QEEG)) will measure brain electrical signals before and after HBOT. An overnight sleep study will measure the quality and stages of sleep pre- and post-HBOT. Blood tests will measure inflammation and cellular mitochondrial function (energy production by the cell) before and after HBOT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxygen 100 % Gas for Inhalation | Oxygen 100% Gas for Inhalation in Hyperbaric Oxygen Therapy Chamber at 1.5 ATA |
| DEVICE | Hyperbaric Oxygen Therapy Chamber | Hyperbaric Oxygen Therapy, 40 treatments, at 1.5 ATA and 100% Oxygen |
Timeline
- Start date
- 2021-09-07
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
- First posted
- 2024-10-30
- Last updated
- 2025-08-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06665633. Inclusion in this directory is not an endorsement.