About this trial
The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are:
1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions? 2. Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment?
Approximately 54 participants will:
* Complete medical and behavioral health screening. * Complete cognitive tests and questionnaires before and after treatment. * Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions.
All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 75 years.
Current or former first responder.
Clinically diagnosed with a traumatic brain injury (TBI) and current or persistent post-concussive syndrome, as determined by a qualified health care professional.
Participants with comorbid PTSD, depression, or anxiety may be enrolled if all other eligibility criteria are met; these symptoms will be assessed as secondary/exploratory outcomes.
Disqualifiers
Untreated pneumothorax
History of spontaneous pneumothorax
Severe sinus infection
Upper respiratory infection
Trial design
Single group
Treatments tested in this trial
Hyperbaric Oxygen Therapy (HBOT)
DrugParticipants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment.
Treatment groups
Trial outcomes
Primary outcomes
Change in NeuroTrax Global Cognitive Score
Change in Global Cognitive Score from baseline to completion of 40 HBOT sessions.
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Change in post-concussive symptom score from baseline to completion of 40 HBOT sessions.
Secondary outcomes
Change in PTSD Checklist for DSM-5 (PCL-5) score
Change in PTSD symptom score from baseline to completion of 40 HBOT sessions.
Change in Patient Health Questionnaire-9 (PHQ-9) score
Change in depression symptom score from baseline to completion of 40 HBOT sessions.
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Change in anxiety symptom score from baseline to completion of 40 HBOT sessions.
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores
Change in quality-of-life scores from baseline to completion of 40 HBOT sessions.
Sponsors and contacts
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