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Can pressurized oxygen ease persistent concussion woes?

NCT ID NCT05173818

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) can help adults with persistent post-concussion symptoms like headaches, fatigue, and memory problems. Twenty participants with mild traumatic brain injury received either real treatment or a sham procedure over 40 sessions. The goal was to see if the therapy improves thinking skills and reduces a brain-damage marker in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperbaric oxygen therapy
What this could lead to
If it works, this could offer a new treatment option for people with long-lasting concussion symptoms that haven't improved with other therapies.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply to everyone. The sham control also involves some pressure, which could reduce the apparent benefit.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Jun 2022

Finished

Aug 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 years and older

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: * Volunteers must have a history of mild traumatic brain injury, specifically, persistent post-concussive symptoms after examination by a neuropsychologist or neurologist. * Volunteers time from concussive incident (Mild traumatic brain injury) must be between 3 months - 5 years following head trauma incident * TBI was caused by non-penetrating trauma * Volunteers must have current complaints of TBI symptoms such as headache, dizziness, or cognitive or affective problems * Volunteers must be 18-year-old or more * Willing and able to provide informed consent * Able to speak and read English, as primary language * Agrees to provide blood samples for clinical lab tests * Willing and committed to comply with research protocol and complete all outcome measures * Able to equalize middle ear pressures or willing to undergo needle myringotomies if needed * Willingness and committed to comply with study protocol outlined reproductive plan based on baseline reproductive status Exclusion Criteria: * Prior treatment with hyperbaric oxygen treatment * Hyperbaric chamber inside attendant, professional, SCUBA diver (technical, commercial, operational/military or recreational) * The investigators will exclude pregnant women from this study because potential fetal adverse reactions triggered by high oxygen partial pressures such as retrolenticular fibroplasia though careful review of human data are generally reassuring such as the use of hyperbaric oxygen to treat acute carbon monoxide poison in the pregnant patient.13 * Prisoners * Minors * Unable to protect airway or requires frequent suctioning * Known or suspected peri-lymphatic fistula * Presence of tracheostomy (due to limitations in auto-inflating the middle ear) * Unable to participate fully in outcome assessments * Unable to cooperate with hyperbaric oxygen treatments * Unable to speak and read English, as primary language * Not cooperating with instructions during hyperbaric oxygen treatments such as bringing contraband items into the chamber (such as fire lighter) * Not competent to sign their own consent. Such potential participants will not have the capacity to participate in a full range of neurocognitive testing * Pre-existing diagnosis of a psychotic disorder(s): schizophrenia, bipolar, dissociative disorder * History of moderate or severe traumatic brain injury * History of brain injury not of traumatic etiology such as stroke or drug-induced coma * Verifiable diagnosis of learning disability. Other pre-existing cognitive issues may make it difficult for potential participants to fill out certain outcome assessments such as neurobehavioral symptomatic inventory. This could lead to measurement bias or confound the result. * Claustrophobia and unwilling to enter hyperbaric chamber * Untreated pneumothorax * Presence of implanted device with un-verifiable test to pressure by manufacturer * Concurrent enrollment in an alternate interventional trial for post concussive symptoms

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Essentia Health

    Fargo, North Dakota, 58103, United States

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