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Hyperbaric Oxygen Therapy

Phase 2

TBI Traumatic Brain Injury | Small molecule | Neurology |Summit Therapeutics Inc.|Last Updated: Oct 9, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Hyperbaric Oxygen Therapy · 1 trial · 3 indications

Phase 2 1
NCT07214415Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen TherapyTBI Traumatic Brain Injury
RECRUITING54 Analytics
PHASE2RECRUITING
Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
TBI Traumatic Brain InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

PTSD Checklist for DSM-5 (PCL-5)
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

Self-report questionnaire to assess symptoms of PTSD

NeuroTrax
From baseline assessment prior to first HBOT session to immediately after completion of 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.

Patient Health Questionnaire-9 (PHQ-9)
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

Self-report questionnaire to assess depression severity

Generalized Anxiety Disorder 7-item scale (GAD-7)
From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

Self-report questionnaire to measure anxiety severity

World Health Organization Quality of Life (WHOQOL-BREF)
From baseline assessment prior to first HBOT session to immediately after completion of 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, environment, and spirituality/religion/personal belief domains and facets

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HBOT Intervention GroupEXPERIMENTAL -

Interventions

NameTypeDescription
Hyperbaric Oxygen TherapyDRUGEach 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.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. At least 18 years of age. 2. Veteran status 3. 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. 4. The subject is willing a...

Countries:United States
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Frequently asked questions about Hyperbaric Oxygen Therapy

What is Hyperbaric Oxygen Therapy used for in TBI Traumatic Brain Injury?

Hyperbaric Oxygen Therapy is being studied for use in TBI Traumatic Brain Injury, specifically to evaluate cognitive function, mental health, and quality of life in affected patients. It is an investigational therapy currently in Phase 2 clinical development for this neurological condition.

Who is developing Hyperbaric Oxygen Therapy for TBI?

Summit Therapeutics Inc. (NASDAQ: SMMT) is developing Hyperbaric Oxygen Therapy for TBI Traumatic Brain Injury. The therapy is currently in Phase 2 clinical development for this neurological indication.

What phase is Hyperbaric Oxygen Therapy in for TBI?

Hyperbaric Oxygen Therapy is in Phase 2 clinical development for TBI Traumatic Brain Injury. It is an investigational therapy and has not yet been approved for this use. One Phase 2 trial is currently recruiting participants.

What clinical trials is Hyperbaric Oxygen Therapy in?

Hyperbaric Oxygen Therapy is being evaluated in a Phase 2 clinical trial with the identifier NCT07214415. The trial is titled 'Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy' and is recruiting 54 participants in the United States.

Does Hyperbaric Oxygen Therapy use a biomarker for patient selection?

Yes, Hyperbaric Oxygen Therapy is being studied with biomarker-selected patients in its Phase 2 clinical trial for TBI Traumatic Brain Injury. The trial is uncontrolled and does not use randomization or double-blind design.