An interventional study of Acute Intermittent Hypoxia (AIH) and Task specific Airway Protection Training in Traumatic Brain Injury, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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).
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's enrollment of 5 is below the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
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) · Behavioral: Task specific Airway Protection Training
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 · Other: Sham AIH
Acute intermittent hypoxia refers to brief (acute), repetitive (intermittent) episodes of breathing oxygen-deprived air (hypoxia) alternating with breathing ambient room air.
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.
Also known as: volitional laryngeal vestibule closure (vLVC) training
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.
Duration of laryngeal vestibule closure (dLVC)
Time in (msec) the laryngeal vestibule stays closed during a swallow
Time frame: 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
Time frame: Pre-intervention, 1 day after intervention block and 1-week post intervention
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).
Time frame: Pre-intervention, 1 day after intervention block and 1-week post intervention
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Florida