Long-Term Outcomes Following HBOT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric Oxygen Therapy (HBOT).
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury, Post-Concussive Symptoms, Post-Traumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Summit Hyperbarics and Wellness — Boise
Identifiers
NCT: NCT07732374 · HBOT-VET-2026-002