Recruiting
Phase 2

HBOT

Sponsor:

Summit Hyperbarics and Wellness

Code:

NCT07732374

Conditions

Traumatic Brain Injury

Post-Concussive Symptoms

Post-Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen Therapy (HBOT)

Study Details

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

Study ID

NCT07732374

Start date

Jun 18, 2026

Status verified date

Jun, 2026

Completion date

Jun 18, 2027

Anticipated

Primary completion date

Jun 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least 18 years of age.
2. Veteran status
3. Clinically diagnosed with a mTBI, PCS, PTSD, Anxiety, or Depression disorder.
4. Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).
5. 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.
6. Completed cognitive and psychological measurements.
7. Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
8. Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).

Exclusion Criteria:

1. Acute medical illness or infection
2. Severe or unstable physical disorders or major cognitive deficits
3. Current manic, psychotic episodes, or serious suicidal ideations
4. Non-English speakers
5. Inability to attend scheduled follow-up visits
6. 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.
7. 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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HBOT Follow-Up Cohort

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.

Interventions

Hyperbaric Oxygen Therapy (HBOT)

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.

Primary outcome measure

  • NeuroTrax [ Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session ]
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session ]
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session ]
  • Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session ]
  • World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session ]

Central Contacts and Locations

Central contacts

Locations

Summit Hyperbarics and Wellness

Recruiting

Boise, Idaho, United States, 83716

Contacts

Principal Investigator:

Steven Wyman, MD

More Information

Sponsor

Summit Hyperbarics and Wellness

Last update posted

Jul 28, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Summit Hyperbarics and Wellness on 2026-07-28.