Trial · NCT06665633
Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy
NCT06665633, Phase 1, Completed, Nova Southeastern University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy. Trials, record NCT06665633. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06665633
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy
- NCT number
- NCT06665633
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- Nova Southeastern University
- Conditions
- Mild Traumatic Brain Injury, Hyperbaric Oxygen Therapy, Depression
- Interventions
- Oxygen 100 % Gas for Inhalation, Hyperbaric Oxygen Therapy Chamber
- First posted
- 2024-10-30
- Last updated
- 2025-08-26
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brain SPECT Scan | pre- HBOT and 4 weeks after HBOT | A brain SPECT scan is a type of imaging test that uses a radioactive substance and a special camera to create 3D pictures of the brain. It shows which areas of the brain are functioning the best or worst and how well the blood flows in the brain. The blood flow to the brain was measured pre- and post-HBOT. An infusion of a radioactive tracer, 30 millicurie (mCi) of Tc99m-Ceretec, was injected into the Veteran's IV site. The veteran was placed under the gamma scintillation camera (Siemens E-cam Dual Head) with a low-energy, high-resolution collimator and SPECT images were recorded using the NeuroGam Software Analysis for the numerical calculation of the mean blood flow value for each of the Brodmann Areas - which are the functional areas in the brain. |
| Secondary | Beck Anxiety Inventory | pre- HBOT and 1, 6. 12 months after HBOT | The Beck Anxiety Inventory (BAI) is a validated 21-item self-report questionnaire used to assess the severity of anxiety symptoms. Higher scores indicate more severe symptoms. A score of 0-7 indicates minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety, and 26-63 severe anxiety. |
| Secondary | Beck Depression Inventory II | pre- HBOT and 1, 6. 12 months after HBOT | The Beck Depression Inventory is a validated self-report questionnaire that indicates the severity of depressive symptoms. Scores are typically categorized as minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63) depression, with higher scores indicating more pronounced symptoms. |
| Secondary | Brief Pain Inventory | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated self-report questionnaire used to assess pain in patients. It measures the intensity of pain (severity) and how it interferes with daily activities (interference). It is scored by calculating the mean of the items for pain severity and pain interference, each on a scale of 0-10. The higher the score, the more intense the pain and the more it interferes with daily activities. |
| Secondary | Traumatic Brain Injury Screening Tool | pre- HBOT | Criteria for Mild Traumatic Brain Injury: * Confused/disoriented state that lasts less than 24 hours * Loss of consciousness for up to 30 minutes * Memory loss lasting less than 24 hours * Excluded severe TBI with skull penetrating injury, brain hemorrhage Other cognitive difficulties include feeling dazed, groping for words, and having problems with attention, concentration, processing speed, planning, reasoning, and abstract thinking. Physical symptoms include headache, nausea, vomiting, drowsiness, fatigue, dizziness, loss of balance, blurred vision, unrefreshed sleep, sensitivity to light or sound, tinnitus, and alteration of taste or smell. Some patients also experience mental health symptoms including anxiety, depression, post-traumatic stress disorder, and suicide ideation |
| Secondary | Davidson Trauma Scale | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated 17-item self-report questionnaire used to assess the severity of post-traumatic stress disorder (PTSD) symptoms. The total score, which can range from 0 to 136. Higher scores indicate more severe PTSD symptoms. |
| Secondary | Functional Capacity Scale | pre- HBOT and 1, 6. 12 months after HBOT | Self-report scale from 0 to 10 to measure the severity of fatigue and cognitive ability. Better energy and cognitive function is reflected in a higher number. |
| Secondary | Pittsburgh Sleep Quality Index | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated self-report questionnaire that assesses sleep quality over a one-month time interval. The sum of these component scores yields a global PSQI score, ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is generally considered indicative of poor sleep quality. |
| Secondary | The Quick Environmental Exposure and Sensitivity Inventory (QEESI) | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated self-report questionnaire that helps researchers, doctors, and their patients identify individuals with multiple chemical intolerances and their responses to the chemicals. The score is 0-10 with the higher score indicating a worse response to chemical exposures. |
| Secondary | Short-Form 36 Health Survey | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated questionnaire used to measure health-related quality of life. It has eight scaled scores, each ranging from 0 to 100, with lower scores indicating more disability and higher scores indicating less disability. The eight scales are physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Simple Reaction Time | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06665633
GET https://conductscience.org/api/trials/v1/NCT06665633/registered?page=2