RecruitingPhase 2

HBOT Effects on First Responders' Cognition and Well-Being

Changes in Cognitive Functioning, Psychological Well-Being, and Quality of Life Following Hyperbaric Oxygen Therapy in First Responders

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Approximately 54 participants will: * Complete medical and behavioral health screening. * Complete cognitive tests and questionnaires before and after treatment. * Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions."
  • "Eligible participants will complete baseline cognitive testing and questionnaires measuring post-concussive symptoms, psychological symptoms, and quality of life."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests changes in thinking, lasting concussion symptoms, and well-being after 40 hyperbaric oxygen therapy (HBOT) sessions, which use oxygen under higher pressure. It is for current or former first responders with a diagnosed brain injury and lasting symptoms. Everyone gets HBOT, so the study cannot show whether HBOT caused any changes.

The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are: 1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions? 2. Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment? Approximately 54 participants will: * Complete medical and behavioral health screening. * Complete cognitive tests and questionnaires before and after treatment. * Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions. All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 75 years old and a current or former first responder.
  • Have a brain injury and lasting concussion symptoms diagnosed by a qualified health care professional.
  • Have symptoms that seriously affect work, social life, or other important daily activities.
  • Be able to read, understand, and freely sign the study consent form.
  • Complete thinking and mental health tests before treatment.
  • People with PTSD, depression, or anxiety may join if they meet all other study rules.
  • If sexually active and you or your female partner could become pregnant, agree to use accepted birth control during the study and for 30 days after the last HBOT session.
  • If taking medicines that affect mood, thinking, or behavior, have a stable medicine plan for a period approved by the study doctor.

Who can't join

  • An untreated collapsed lung or past lung collapse without an injury; COPD or emphysema (long-term lung diseases); or abnormal lung areas on a chest X-ray, even without symptoms.
  • A severe sinus infection, upper airway infection, middle ear infection, uncontrolled fever over 39°C, cough, congestion, vomiting, diarrhea, or open wounds.
  • Past chest or ear surgery, including ear tubes; past surgery or laser treatment to repair the retina (the back of the eye); or past inflammation of the nerve used for sight or sudden blindness.
  • Any anemia or blood disorder, including inherited sphere-shaped red blood cells; a seizure disorder; diabetes treated with insulin; or a sudden drop in blood sugar.
  • Pregnancy or breastfeeding; nicotine use, substance use, or addiction; or active cancer.
  • Current episodes of extreme high mood, false beliefs, or loss of touch with reality; serious or current thoughts of suicide; severe or unstable physical illness; or major thinking problems.
  • Unable to attend visits or follow study rules, unable to speak English, any past HBOT treatment, or age over 75.
  • Use during the study of certain medicines: antimetabolites such as methotrexate or azathioprine; chemotherapy such as cyclophosphamide or cisplatin; mafenide acetate; disulfiram; blood-vessel-widening drugs that interact with oxygen, such as nitroglycerin; or antibiotics with known HBOT risks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria 1. Adults aged 18 to 75 years. 2. Current or former first responder. 3. Clinically diagnosed with a traumatic brain injury (TBI) and current or persistent post-concussive syndrome, as determined by a qualified health care professional. 4. Participants with comorbid PTSD, depression, or anxiety may be enrolled if all other eligibility criteria are met; these symptoms will be assessed as secondary/exploratory outcomes. 5. Ability to provide informed consent, including the ability to read, understand, and voluntarily sign the informed consent document. 6. Completion of baseline cognitive and psychological assessment measures as part of study enrollment procedures. 7. Presence of clinically significant symptoms resulting in functional impairment in occupational, social, or other key areas of functioning, as determined by clinical evaluation. 8. Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session. 9. Stable regimen of psychoactive medications (if applicable), including antidepressants, anxiolytics, antipsychotics, stimulants, and mood stabilizers, for a clinically appropriate stabilization period prior to enrollment, as determined by the study physician. Exclusion criteria 1. Untreated pneumothorax 2. History of spontaneous pneumothorax 3. Severe sinus infection 4. Upper respiratory infection 5. Asymptomatic pulmonary lesions on chest x-ray 6. Uncontrollable high fever (greater than 39C) 7. History of chest or ear surgery 8. Congenital spherocytosis 9. Any anemia or blood disorder 10. Any convulsive disorder 11. History of optic neuritis or sudden blindness 12. Middle ear infection 13. Diabetes mellitus (insulin therapy) 14. The participant is pregnant or lactating 15. Nicotine use/substance use/addiction 16. Acute Hypoglycemia 17. Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema 18. Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds. 19. Active malignancy 20. Current manic, delusional, or psychotic episodes 21. Serious/current suicidal ideations 22. Severe or unstable physical disorders or major cognitive deficits 23. Inability to attend scheduled clinic visits or comply with study protocols. 24. Treated with HBOT for any reason prior to study enrollment. 25. Non-English speakers 26. History of retinal repair, including laser photocoagulation or retinal detachment surgery. 27. History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement. 28. Age greater than 75 years. 29. Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapuetic agents (e.g., cyclophosphamide, cisplatin); Mafenide acetate e.g., Sulfamylon); Disulfiram (e.g, Antabuse); Peripheral vasodilators known to interact with oxygen exposure (e.g., nitroglycerin); and Antibacterial drugs with known HBOT interaction risks.

Study sites (1)

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