CompletedNot Applicable

Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury

United States5 participantsStarted 2024-08-30

Plain-language summary

Acute intermittent hypoxia (AIH) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. Animal and human studies show that AIH improves motor function after neural injury, particularly when paired with task-specific training. Using a double blind cross-over study we will test whether AIH and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (TBI).

Who can participate

Age range

21 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of laryngeal vestibule closure (dLVC)

Timeframe: Pre-intervention, 1 day after intervention block and 1-week post intervention

Time to laryngeal vestibule closure (Time-to-LVC)

Timeframe: Pre-intervention, 1 day after intervention block and 1-week post intervention

Trial details

NCT IDNCT06520358

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Traumatic Brain Injury trials