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Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy

NCT06665633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-26

No results posted yet for this study

Summary

Mild traumatic brain (mTBI) injury affects 400,000 U.S. Veterans resulting in physical, cognitive and mental health symptoms. The Department of Defense (DoD) reported 26 suicides a day from mTBI despite ongoing care for the Veterans. The purpose of this pilot research study is to evaluate the effect of treating Veterans suffering from mTBI or persistent post-concussion syndrome with hyperbaric oxygen therapy (HBOT).

Conditions

  • Mild Traumatic Brain Injury
  • Hyperbaric Oxygen Therapy
  • Depression

Interventions

DRUG

Oxygen 100 % Gas for Inhalation

Oxygen 100% Gas for Inhalation in Hyperbaric Oxygen Therapy Chamber at 1.5 ATA

DEVICE

Hyperbaric Oxygen Therapy Chamber

Hyperbaric Oxygen Therapy, 40 treatments, at 1.5 ATA and 100% Oxygen

Sponsors & Collaborators

  • Nova Southeastern University

    lead OTHER

Principal Investigators

  • Alison C Bested, MD FRCPC · Nova Southeastern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2025-07-01
Completion
2025-07-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665633 on ClinicalTrials.gov