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

January 7, 2026 updated by: University of Florida
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent studies have found that acute intermittent hypoxia (AIH)-or repetitive exposure to brief episodes of low inspired oxygen--is a promising new strategy that can help restore motor function by promoting neuroplasticity throughout the central nervous system (CNS). Both rodent and human studies show that motor function is further enhanced when AIH is paired with task-specific training/rehabilitation (TST). Therefore, this study will investigate the therapeutic potential of combining AIH with a task-specific airway protection training. We propose that the combined use of AIH + TST will enhance the magnitude and duration of TST training alone in individuals with chronic traumatic brain injury.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AIH + TST
Participants will complete a 5-day intervention blocks where they receive daily AIH followed by task specific airway protection training 60 minutes after the AIH exposure. Each exposure involves a 1-minute delivery of low oxygen (9-11% inspired O2), followed by a 1.5-min interval of room air breathing (21% O2). This method of waiting 45-60 minutes after the delivery of AIH and prior to engaging in task-specific training/rehabilitation enables sufficient time to increase brain derived neurotrophic factor (BDNF) following AIH, thereby augmenting the impact of task-specific training.
Other: Acute Intermittent Hypoxia (AIH)
Acute intermittent hypoxia refers to brief (acute), repetitive (intermittent) episodes of breathing oxygen-deprived air (hypoxia) alternating with breathing ambient room air.
Behavioral: Task specific Airway Protection Training
The vLVC maneuver involves training participants to volitionally prolong closure of the laryngeal vestibule during swallowing, beginning with swallow onset and sustaining closure for at least 2 seconds.
Other Names:
  • volitional laryngeal vestibule closure (vLVC) training
Sham Comparator: Sham AIH + TST
Participants will complete a 5-day intervention blocks where they receive sham AIH followed by task specific airway protection training 60 minutes after the AIH sham exposure. Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.
Behavioral: Task specific Airway Protection Training
The vLVC maneuver involves training participants to volitionally prolong closure of the laryngeal vestibule during swallowing, beginning with swallow onset and sustaining closure for at least 2 seconds.
Other Names:
  • volitional laryngeal vestibule closure (vLVC) training
Other: Sham AIH
Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of laryngeal vestibule closure (dLVC)
Time Frame: Pre-intervention, 1 day after intervention block and 1-week post intervention
Time in (msec) the laryngeal vestibule stays closed during a swallow
Pre-intervention, 1 day after intervention block and 1-week post intervention
Time to laryngeal vestibule closure (Time-to-LVC)
Time Frame: Pre-intervention, 1 day after intervention block and 1-week post intervention
Time in (msec) it takes to close the laryngeal vestibule after swallow initiation
Pre-intervention, 1 day after intervention block and 1-week post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration-Aspiration Scale Scores
Time Frame: Pre-intervention, 1 day after intervention block and 1-week post intervention
The penetration-aspiration scale (PAS) will be used to assess penetration or aspiration; the PAS is an 8-point scale that ranges from 1 (no penetration/aspiration) to 8 (aspiration with no cough response).
Pre-intervention, 1 day after intervention block and 1-week post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Alicia Z Vose, Ph.D., University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202301156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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