Long-Term Outcomes Following HBOT

NCT07732374 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HBOT-VET-2026-002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.

Conditions

Traumatic Brain Injury; Post-Concussive Symptoms; Post-Traumatic Stress Disorder

Keywords

Hyperbaric Oxygen Therapy; Treatment Durability; Cognitive Function; Mental Health; Quality of Life; Veterans; Traumatic Brain Injury; Persistent Post-Concussive Symptoms (PCS)

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline (post-HBOT completion) and 12 weeks after the final HBOT session

• PTSD Checklist for DSM-5 (PCL-5)

  Self-report questionnaire to assess symptoms of PTSD

  Baseline (post-HBOT completion) and 12 weeks after the final HBOT session

• Patient Health Questionnaire-9 (PHQ-9)

  Self-report questionnaire to assess depression severity

  Baseline (post-HBOT completion) and 12 weeks after the final HBOT session

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

  Self-report questionnaire to measure anxiety severity

  Baseline (post-HBOT completion) and 12 weeks after the 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, and environment facets

  Baseline (post-HBOT completion) and 12 weeks after the final HBOT session

Study Arms (1)

HBOT Follow-Up Cohort

EXPERIMENTAL

Veterans who previously completed a standardized Hyperbaric Oxygen Therapy (HBOT) treatment protocol and undergo follow-up assessments approximately 12 weeks after their final treatment session to evaluate the long-term durability of cognitive, psychological, and quality-of-life outcomes.

Drug: Hyperbaric Oxygen Therapy (HBOT)

Interventions

Hyperbaric Oxygen Therapy (HBOT) DRUG

Hyperbaric Oxygen Therapy (HBOT): Participants will receive 100% medical oxygen (USP) administered under hyperbaric conditions at 2.0 atmospheres absolute (ATA) for 60 minutes with a scheduled air break over 40 treatment sessions.

Also known as: Hyperbaric Oxygen, Hyperbaric Oxygen Treatment

HBOT Follow-Up Cohort

Eligibility Criteria

• Age: 18 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, PCS, PTSD, Anxiety, or Depression disorder.
• Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).
• Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently.
• Completed cognitive and psychological measurements.
• Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
• Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).

You may not qualify if:

• Acute medical illness or infection
• Severe or unstable physical disorders or major cognitive deficits
• Current manic, psychotic episodes, or serious suicidal ideations
• Non-English speakers
• Inability to attend scheduled follow-up visits
• Significant life events, new neurological injury, or new psychiatric diagnosis or hospitalization occurring after completion of the HBOT intervention that, in the opinion of the investigator, could confound cognitive, psychological, or quality-of-life outcomes.
• Participation in another interventional clinical study or receipt of a therapeutic intervention following completion of HBOT that could influence cognitive, psychological, or quality-of-life outcomes.

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; Post-Concussion Syndrome; Stress Disorders, Post-Traumatic; Psychological Well-Being

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; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

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: Principal Investigator

Model Details: This study utilizes a quasi-longitudinal design incorporating follow-up assessments to examine the sustained effects of Hyperbaric Oxygen Therapy (HBOT) on cognitive function, mental health, and quality of life in a cohort of veterans. Follow-up evaluations will employ validated cognitive and psychometric instruments to assess the durability of HBOT's therapeutic effects post-intervention. The post-treatment assessment is scheduled 12 weeks after each subject's final HBOT session.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): June 18, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)