HBOT Effects on First Responders' Cognition and Well-Being

NCT07852728 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HBOT-FR-2026-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Traumatic Brain Injury; PTSD - Post Traumatic Stress Disorder; Anxiety; Depression; Post Concussion Symptoms

Keywords

First responders; Traumatic Brain Injury (TBI); Post Concussion Symptoms; Hyperbaric Oxygen Therapy (HBOT); Cognitive Functioning; Post-traumatic stress disorder (PTSD); Depression; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Change in NeuroTrax Global Cognitive Score

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

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

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

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

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

Secondary Outcomes (4)

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

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

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

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

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

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

• Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores

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

Study Arms (1)

Hyperbaric Oxygen Therapy

EXPERIMENTAL

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.

Drug: Hyperbaric Oxygen Therapy (HBOT)

Interventions

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.

Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to provide informed consent, including the ability to read, understand, and voluntarily sign the informed consent document.
• Completion of baseline cognitive and psychological assessment measures as part of study enrollment procedures.
• Presence of clinically significant symptoms resulting in functional impairment in occupational, social, or other key areas of functioning, as determined by clinical evaluation.
• Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session.
• Stable regimen of psychoactive medications (if applicable), including antidepressants, anxiolytics, antipsychotics, stimulants, and mood stabilizers, for a clinically appropriate stabilization period prior to enrollment, as determined by the study physician.

You may not qualify if:

• Untreated pneumothorax
• History of spontaneous pneumothorax
• Severe sinus infection
• Upper respiratory infection
• Asymptomatic pulmonary lesions on chest x-ray
• Uncontrollable high fever (greater than 39C)
• History of chest or ear surgery
• Congenital spherocytosis
• Any anemia or blood disorder
• Any convulsive disorder
• History of optic neuritis or sudden blindness
• Middle ear infection
• Diabetes mellitus (insulin therapy)
• The participant is pregnant or lactating
• Nicotine use/substance use/addiction

Sponsors & Collaborators

• Summit Hyperbarics and Wellness: lead

Study Sites (1)

Summit Hyperbarics and Wellness

Boise, Idaho, 83716, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Combat Disorders; Anxiety Disorders; Depression; Post-Concussion Syndrome; Stress Disorders, Post-Traumatic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Steve Wyman, MD

  Summit Hyperbarics and Wellness

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Troy Nickel, Ph.D.

CONTACT

208-813-9541; tnickel@shwidaho.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Hyperbaric Oxygen Therapy (HBOT): Participants will receive 40 sessions in a multiplace hyperbaric chamber at 2.0 atmospheres absolute (ATA). Each session includes two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: September 11, 2026
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)