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Can pressurized oxygen ease lingering concussion woes?

NCT ID NCT05643482

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study tested whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) could help people with persistent symptoms after a mild concussion. Twelve adults who had symptoms for 3 to 12 months after their injury received either real or fake (sham) treatments. The goal was to see if the therapy could reduce headaches, dizziness, and other post-concussion issues, and improve thinking and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Mar 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have been evaluated within 3 weeks of injury and given a diagnosis of concussion by a medical professional * Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ). Exclusion Criteria: Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to: 1. Pulmonary: * COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs * Current pneumothorax or previous spontaneous pneumothorax 2. Cardiac: * Uncontrolled HTN (systolic \>180 or diastolic \>100) * Known Ejection fraction \< 35% * Pacemaker / ICD in place (not approved for chamber use) 3. Hematological/Oncological: * Current chemotherapeutic drug use, and past history of bleomycin use. * Hereditary Spherocytosis * Sickle cell anemia 4. Neurological and Psychological: * Implanted nerve stimulators * Uncontrolled seizure disorder * Drug or alcohol abuse/dependence * Current treatment for alcohol cessation with disulfiram * Claustrophobia 5. Head and Neck: * Inability to equilibrate the pressure of middle ears and sinuses * Current or previous retinal detachment * Retinal or vitreous surgery within the past 3 months 6. Miscellaneous: * Current fever or active infection * Implanted devices not on the approved list for use with HBOT * Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for \>2 years. * Undergoing vestibular or other therapy during the intervention * Planning a change in medication during the intervention 7. Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study. * Asthma * Optic neuritis * Otosclerosis surgery * Thoracic surgery * Chronic sinusitis 8. Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician. * Antabuse - Predisposes to oxygen toxicity * Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria * Meclizine - Predisposes to oxygen toxicity * Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment. * Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings. * Narcotics - Can lead to cessation of the hypoxic respiratory drive. * Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory. * Penicillin - Predisposes to oxygen toxicity * Promethazine (Phenergan) - Predisposes to oxygen toxicity. * Corticosteroids - Decreases the threshold for oxygen toxicity. * Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.

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Conditions

The condition(s) this trial relates to.

Post-Concussion Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center

    Dallas, Texas, 75231, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.