Long-Term Outcomes Following HBOT

July 23, 2026 updated by: Steve Wyman, Summit Hyperbarics and Wellness

Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate the long-term effects of hyperbaric oxygen therapy (HBOT) following the completion of treatment. While previous research has demonstrated promising improvements, less is known about whether these benefits are sustained over time or whether additional improvements continue to emerge after treatment has ended.

The primary objective of this study is to evaluate the persistence of therapeutic effects following the completion of Hyperbaric Oxygen Therapy (HBOT) in veterans, with a focus on cognitive function and symptom reduction related to PTSD, depression, and anxiety. Follow-up assessments will be conducted 12 weeks post-treatment to determine the durability of these outcomes.

The second objective is to evaluate potential delayed (latency) effects of HBOT on cognitive performance, psychological symptoms (e.g., PTSD, depression, anxiety), and functional status.

The findings of this study will help identify the persistence of treatment effects, characterize the timeline of durability, and strengthen the scientific evidence supporting the long-term use of HBOT for individuals with traumatic brain injury, persistent post-concussive symptoms, and post-traumatic stress disorder.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83716
        • Recruiting
        • Summit Hyperbarics and Wellness
        • Contact:
        • Principal Investigator:
          • Steven Wyman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • Hyperbaric Oxygen
  • Hyperbaric Oxygen Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NeuroTrax
Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
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)
Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
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)
Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
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)
Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
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)
Time Frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summit Hyperbarics and Wellness

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2026

Primary Completion (Estimated)

June 18, 2027

Study Completion (Estimated)

June 18, 2027

Study Registration Dates

First Submitted

July 23, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBOT-VET-2026-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Given that our study involves a relatively small cohort of veterans and includes sensitive cognitive and mental health data, we selected "no" to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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