Long-Term Outcomes Following HBOT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Hyperbarics and Wellness
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hyperbaric Oxygen Therapy (HBOT)
DrugHyperbaric 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: HBOT Follow-Up CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Baseline (post-HBOT completion) and 12 weeks after the final HBOT session2
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire to assess symptoms of PTSD
Time frame
Baseline (post-HBOT completion) and 12 weeks after the final HBOT session3
Patient Health Questionnaire-9 (PHQ-9)
Self-report questionnaire to assess depression severity
Time frame
Baseline (post-HBOT completion) and 12 weeks after the final HBOT session4
Generalized Anxiety Disorder 7-item scale (GAD-7)
Self-report questionnaire to measure anxiety severity
Time frame
Baseline (post-HBOT completion) and 12 weeks after the final HBOT sessionSponsors and contacts
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Source ClinicalTrials.gov