Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID07214415

Evaluating the Effects of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans

Led by Summit Hyperbarics and Wellness · Updated on 2025-10-09

54

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how hyperbaric oxygen therapy (HBOT) may impact cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans. It specifically investigates whether HBOT improves these areas by comparing assessments taken before and after treatment while considering demographic factors. The study is designed as a Phase 2 interventional trial focusing on veterans diagnosed with related mental health and brain injury conditions. Participants receive hyperbaric oxygen therapy sessions lasting about 95 minutes each. Sessions include gradual pressure changes to 2.0 ATA, two 30-minute periods of breathing 100% oxygen separated by a 5-minute air break, all under medical supervision with safety protocols. After medical and behavioral screening, veterans undergo baseline cognitive, mental health, and quality of life assessments before starting HBOT and repeat them after completing the treatment course. During the study, participants complete questionnaires and tests measuring PTSD symptoms, cognitive function, depression, anxiety, and quality of life both before and immediately after treatment. These include the PTSD Checklist for DSM-5, NeuroTrax cognitive testing, Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-item scale, and WHO Quality of Life questionnaire. The study monitors participant safety and adherence throughout, with total involvement lasting from baseline assessment through the end of HBOT sessions.

CONDITIONS

Brief Title

Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Veteran status
  • Clinically diagnosed with mild traumatic brain injury, PTSD, anxiety, or depression by a qualified professional
  • Able and willing to read, understand, and sign informed consent with clear consciousness and independent self-expression
  • Exposure to at least one trauma-focused or evidence-based psychotherapy such as prolonged exposure, EMDR, or CBT
  • Completed cognitive and psychological assessments
  • Diagnoses cause significant impairment in social, occupational, or other functional areas
  • Sexually active females of childbearing potential and males with partners of childbearing potential agree to use contraception during the study and for 30 days after final treatment
  • Stable on current psychoactive medications including antidepressants, anti-anxiety meds, antipsychotics, stimulants, or mood stabilizers
Not Eligible

You will not qualify if you...

  • Untreated pneumothorax or history of spontaneous pneumothorax
  • Severe sinus or respiratory infections
  • Asymptomatic pulmonary lesions on chest x-ray
  • Uncontrollable high fever above 39C
  • History of chest or ear surgery
  • Congenital spherocytosis or any anemia/blood disorders
  • Any convulsive disorder
  • History of optic neuritis or sudden blindness
  • Middle ear infection
  • Diabetes mellitus requiring insulin therapy
  • Pregnancy or lactation
  • Nicotine or substance use/addiction
  • Acute hypoglycemia
  • Diagnosed COPD or emphysema
  • Symptoms like cough, congestion, vomiting, diarrhea, or open wounds
  • Active malignancy
  • Current manic, delusional, or psychotic episodes
  • Serious or current suicidal thoughts
  • Severe or unstable physical disorders or major cognitive deficits
  • Inability to attend visits or comply with study
  • Prior treatment with HBOT
  • Non-English speakers
  • History of retinal repair or middle ear surgeries including tympanoplasty, mastoidectomy, or pressure equalization tube placement
  • Age over 75 years
  • Use of certain medications that interact with oxygen exposure during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - Duration not specified

Participants receive Hyperbaric Oxygen Therapy sessions under direct medical supervision, including cognitive, mental health, and quality of life assessments before and after treatment.

1 baseline visit and 1 follow-up visit after completing therapy

Trial Site Locations

Total: 1 location

1

Summit Hyperbarics and Wellness

Boise, Idaho, United States, 83716

Actively Recruiting

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Research Team

T

Troy Nickel, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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