Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy

NCT07214415 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: HBOT-VET-2025-00120253309
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.

1. 1.Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores?
2. 2.To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.

Conditions

TBI Traumatic Brain Injury; PTSD - Post Traumatic Stress Disorder; Post Concussive Syndrome

Outcome Measures

Primary Outcomes (5)

• PTSD Checklist for DSM-5 (PCL-5)

  Self-report questionnaire to assess symptoms of PTSD

  From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

• NeuroTrax

  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.

  From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.

• Patient Health Questionnaire-9 (PHQ-9)

  Self-report questionnaire to assess depression severity

  From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

• Generalized Anxiety Disorder 7-item scale (GAD-7)

  Self-report questionnaire to measure anxiety severity

  From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

• World Health Organization Quality of Life (WHOQOL-BREF)

  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

  From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

Study Arms (1)

HBOT Intervention Group

EXPERIMENTAL

Drug: Hyperbaric Oxygen Therapy

Interventions

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.

HBOT Intervention Group

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age.
• Veteran status
• 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.
• The subject is willing and able to read, understand, and sign an informed consent. Additionally, the subject has clear consciousness and the ability to express self-feelings independently.
• Exposed to at least one trauma-focused therapy or evidence-based psychotherapeutic treatment, such as prolonged exposure therapy, EMDR, or CBT, to name a few.
• Completed cognitive and psychological measurements.
• Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
• 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.
• Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).

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 subject 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; Post-Concussion Syndrome

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; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Steven Wyman, MD

  Summit Hyperbarics and Wellness

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Troy Nickel, PhD

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

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-09

Locations

US (1)