HBOT Effects on First Responders' Cognition and Well-Being

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSummit Hyperbarics and Wellness

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Hyperbaric Oxygen Therapy (HBOT)

    Drug

    Participants 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

54 Participants
are divided into 1 treatment group
Group A: Hyperbaric Oxygen TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in NeuroTrax Global Cognitive Score

Change in Global Cognitive Score from baseline to completion of 40 HBOT sessions.

Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
2

Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score

Change in post-concussive symptom score from baseline to completion of 40 HBOT sessions.

Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

Secondary outcomes

1

Change in PTSD Checklist for DSM-5 (PCL-5) score

Change in PTSD symptom score from baseline to completion of 40 HBOT sessions.

Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
2

Change in Patient Health Questionnaire-9 (PHQ-9) score

Change in depression symptom score from baseline to completion of 40 HBOT sessions.

Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
3

Change in Generalized Anxiety Disorder-7 (GAD-7) score

Change in anxiety symptom score from baseline to completion of 40 HBOT sessions.

Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
4

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.

Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.