Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07214415 | Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy | PHASE2 | RECRUITING | 54 | — | — | Oct 1, 2025 | Sep 15, 2026 | Oct 9, 2025 | 1 | United States |
Self-report questionnaire to assess symptoms of PTSD
A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills.
Self-report questionnaire to assess depression severity
Self-report questionnaire to measure anxiety severity
Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal belief domains and facets
| Arm | Type | Description |
|---|---|---|
| HBOT Intervention Group | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Hyperbaric Oxygen Therapy | DRUG | Each HBOT session is scheduled for approximately 95 minutes. The session will begin with a descent of up to 15 minutes (longer if needed for comfort/safety) to a pressure of 2.0 ATA, followed by 30 minutes of breathing 100% oxygen. At the midpoint, there will be a 5-minute air break from oxygen, after which subjects resume breathing 100% oxygen for another 30 minutes. Finally, the session will conclude with an ascent of up to 15 minutes (longer if needed for comfort/safety) back to 1.0 ATA. All sessions are delivered under direct medical supervision with standardized safety protocols. Once approved after medical and behavioral screening, participants complete a battery of cognitive, mental health, and quality of life assessments at baseline (pre-) and after completing the therapy (post-). This arm is distinct from any sham or control interventions because all participants receive the active HBOT treatment. |
Inclusion Criteria: 1. At least 18 years of age. 2. Veteran status 3. Clinically diagnosed with a mTBI, PTSD, Anxiety, or Depression disorder by meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and by a qualified and trained professional. 4. The subject is willing a...