Traumatic Brain InjuryNCT06520358
Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
A study testing Acute Intermittent Hypoxia (AIH) and Task specific Airway Protection Training in people with Traumatic Brain Injury, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Acute Intermittent Hypoxia (AIH) and Task specific Airway Protection Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Acute Intermittent Hypoxia (AIH), Task specific Airway Protection Training, Sham AIH
- Keywords
- acute intermittent hypoxia, rehabilitation, airway protection, dysphagia
- Medical subject headings
- Brain Injuries, Traumatic, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent Hypoxia (AIH)Other
Acute intermittent hypoxia refers to brief (acute), repetitive (intermittent) episodes of breathing oxygen-deprived air (hypoxia) alternating with breathing ambient room air.
Task specific Airway Protection TrainingBehavioural
Also called volitional laryngeal vestibule closure (vLVC) 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.
Sham AIHOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AIH + TST | Active comparator | 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. Receives: Other: Acute Intermittent Hypoxia (AIH); Behavioral: Task specific Airway Protection Training |
| Sham AIH + TST | Sham comparator | 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. Receives: Behavioral: Task specific Airway Protection Training; Other: Sham AIH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of laryngeal vestibule closure (dLVC)
Time in (msec) the laryngeal vestibule stays closed during a swallow
Measured: Pre-intervention, 1 day after intervention block and 1-week post intervention
Time to laryngeal vestibule closure (Time-to-LVC)
Time in (msec) it takes to close the laryngeal vestibule after swallow initiation
Measured: Pre-intervention, 1 day after intervention block and 1-week post intervention
Secondary outcomes (1)
Penetration-Aspiration Scale Scores
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).
Measured: Pre-intervention, 1 day after intervention block and 1-week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 Aug 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The pilot study will utilize a double-blind, placebo-controlled, randomized-order, repeated-measures, cross-over experimental design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Z Vose, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520358
- Sponsor's protocol ID
- IRB202301156
- Status last verified
- Nov 2024
- First submitted
- 19 Jul 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vose AK, Welch JF, Nair J, Dale EA, Fox EJ, Muir GD, Trumbower RD, Mitchell GS. Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. Exp Neurol. 2022 Jan;347:113891. doi: 10.1016/j.expneurol.2021.113891. Epub 2021 Oct 9.
PubMed 34637802Welch JF, Sutor TW, Vose AK, Perim RR, Fox EJ, Mitchell GS. Synergy between Acute Intermittent Hypoxia and Task-Specific Training. Exerc Sport Sci Rev. 2020 Jul;48(3):125-132. doi: 10.1249/JES.0000000000000222.
PubMed 32412926Vose A, Humbert I. "Hidden in Plain Sight": A Descriptive Review of Laryngeal Vestibule Closure. Dysphagia. 2019 Jun;34(3):281-289. doi: 10.1007/s00455-018-9928-1. Epub 2018 Jul 30.
PubMed 30062547
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06520358
- Acronym / sponsor ID
- IRB202301156
- Conditions
- Traumatic Brain Injury
- Keywords
- acute intermittent hypoxia, rehabilitation, airway protection, dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The pilot study will utilize a double-blind, placebo-controlled, randomized-order, repeated-measures, cross-over experimental design
| Arm | Type | Receives |
|---|---|---|
| AIH + TST | Active comparator | Other: Acute Intermittent Hypoxia (AIH), Behavioral: Task specific Airway Protection TrainingParticipants 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. |
| Sham AIH + TST | Sham comparator | Behavioral: Task specific Airway Protection Training, Other: Sham AIHParticipants 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | AIH + TST |
| Task specific Airway Protection TrainingAlso: volitional laryngeal vestibule closure (vLVC) trainingThe 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. | Behavioural | AIH + TST, Sham AIH + TST |
| Sham AIHSham 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. | Other | Sham AIH + TST |
Primary outcome
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
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
1 secondary outcome
Penetration-Aspiration Scale Scores
Time frame: Pre-intervention, 1 day after intervention block and 1-week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 34637802Vose AK, Welch JF, Nair J, Dale EA, Fox EJ, Muir GD, Trumbower RD, Mitchell GS. Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. Exp Neurol. 2022 Jan;347:113891. doi: 10.1016/j.expneurol.2021.113891. Epub 2021 Oct 9.
- Background: PubMed 32412926Welch JF, Sutor TW, Vose AK, Perim RR, Fox EJ, Mitchell GS. Synergy between Acute Intermittent Hypoxia and Task-Specific Training. Exerc Sport Sci Rev. 2020 Jul;48(3):125-132. doi: 10.1249/JES.0000000000000222.
- Background: PubMed 30062547Vose A, Humbert I. "Hidden in Plain Sight": A Descriptive Review of Laryngeal Vestibule Closure. Dysphagia. 2019 Jun;34(3):281-289. doi: 10.1007/s00455-018-9928-1. Epub 2018 Jul 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Z Vose, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) and Task specific Airway Protection Training in people with Traumatic Brain Injury, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of laryngeal vestibule closure (dLVC) (time frame: Pre-intervention, 1 day after intervention block and 1-week post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06520358, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.