Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSummit Hyperbarics and Wellness
About this trial
The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.
1. Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores? 2. To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age.
Veteran status
Clinically diagnosed with a mTBI, PTSD, Anxiety, or Depression disorder by meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and by a qualified and trained professional.
The subject is willing and able to read, understand, and sign an informed consent. Additionally, the subject has clear consciousness and the ability to express self-feelings independently.
Disqualifiers
Untreated pneumothorax
History of spontaneous pneumothorax
Severe sinus infection
Upper respiratory infection
Trial design
Design model
Single group
Treatments tested in this trial
Hyperbaric Oxygen Therapy
DrugEach HBOT session is scheduled for approximately 95 minutes. The session will begin with a descent of up to 15 minutes (longer if needed for comfort/safety) to a pressure of 2.0 ATA, followed by 30 minutes of breathing 100% oxygen. At the midpoint, there will be a 5-minute air break from oxygen, after which subjects resume breathing 100% oxygen for another 30 minutes. Finally, the session will conclude with an ascent of up to 15 minutes (longer if needed for comfort/safety) back to 1.0 ATA. All sessions are delivered under direct medical supervision with standardized safety protocols. Once approved after medical and behavioral screening, participants complete a battery of cognitive, mental health, and quality of life assessments at baseline (pre-) and after completing the therapy (post-). This arm is distinct from any sham or control interventions because all participants receive the active HBOT treatment.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: HBOT Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire to assess symptoms of PTSD
Time frame
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session2
NeuroTrax
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.
Time frame
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.3
Patient Health Questionnaire-9 (PHQ-9)
Self-report questionnaire to assess depression severity
Time frame
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session4
Generalized Anxiety Disorder 7-item scale (GAD-7)
Self-report questionnaire to measure anxiety severity
Time frame
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT sessionSponsors and contacts
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Source ClinicalTrials.gov