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Breathing thin air to protect your throat: a new hope for TBI swallowing?

NCT ID NCT06520358

Symptom relief Sponsor: University of Florida Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This small study tested a technique called acute intermittent hypoxia (AIH) — breathing low-oxygen air for short periods — to see if it could improve swallowing safety in people with chronic mild-to-moderate traumatic brain injury (TBI). Five adults completed the study, which combined AIH with swallowing exercises. The goal was to see if this approach could reduce the risk of food or liquid going into the lungs (aspiration). Results are not yet reported.

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

5 people

The number who actually took part.

Started

Aug 2024

Finished

Sep 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

21 to 80 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: * Adults aged 21-80 years * A mild to moderate traumatic brain injury (TBI) confirmed by medical records * A Glasgow Coma Scale score between 9-15 * Able to consent independently * Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study Exclusion Criteria: * Other neurological diagnoses or a diagnosis of a severe psychiatric disorder * Severe aphasia preventing a participant from understanding the protocol and consent form * Pre-existing hypoxic pulmonary disease * History of obstructive lung diseases such as chronic obstructive pulmonary disease (COPD) or significant asthma) * Severe hypertension (\>160/100) * History of head and neck cancer * Allergy to barium sulfate * Ischemic cardiac disease

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Deglutition Disorders traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

Contacts and locations

Locations

  • University of Florida

    Jacksonville, Florida, 32209, United States

More trials for these conditions

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