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NCT Number: NCT07732374

Long-Term Outcomes Following HBOT

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Hyperbaric Oxygen, Hyperbaric Oxygen Treatment

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Troy Nickel, PhD

CONTACT

[email protected]

208-813-9541

Sponsors and collaborators

Lead sponsor

Summit Hyperbarics and Wellness

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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