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NCT06581003 · ClinicalTrials.gov registry record · Phase 3
Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
A Phase 3 study of Traumatic Brain Injury and Military Operations, sponsored by University of South Florida.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 1
- Study location
NCT06581003: Recruiting Phase 3 study of Traumatic Brain Injury and Military Operations, sponsored by University of South Florida.
NCT06581003 is a Phase 3 study of Traumatic Brain Injury and Military Operations that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 420 participants, above the 275-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (53% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06581003, a Phase 3 study of Traumatic Brain Injury and Military Operations, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit
Primary Outcome
Measured by the Neurobehavioral Symptom Inventory (NSI). The severity of each symptom on the NSI is measured using a 5-item scale (0-none to 4-very severe) that asks patients to indicate the extent to which each symptom has disturbed them in the previous 2 weeks. The NSI total score is the sum of severity ratings of the 22 symptoms. Cluster scores (domains: physical, cognitive, affective, and sensory) were derived.
Conditions Studied
Interventions
- DRUG Oxygen 99.7 %
- DRUG Oxygen 21 %
Study Locations (1)
Florida
- University of South Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2029-08-15 |
| Phase | Phase 3 |
What NCT06581003 shows while recruiting
NCT06581003 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 275-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (53% higher).
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Oxygen 99.7 % is the first listed.
NCT06581003 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06581003 about?
NCT06581003 is a clinical study titled "Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury". The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy ...
What is the current status of trial NCT06581003?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2024-09-18. Estimated completion is 2029-08-15.
What conditions does trial NCT06581003 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Military Operations.
What interventions are being tested in trial NCT06581003?
The interventions under investigation include: Oxygen 99.7 % (DRUG), Oxygen 21 % (DRUG).
Who is sponsoring clinical trial NCT06581003?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06581003 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06581003's enrollment target sits among peer trials
420 18th of 171 higher than 154 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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