Traumatic Brain Injury
Conditions
Keywords
acute intermittent hypoxia, rehabilitation, airway protection, dysphagia
Brief 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).
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.
Interventions
Acute intermittent hypoxia refers to brief (acute), repetitive (intermittent) episodes of breathing oxygen-deprived air (hypoxia) alternating with breathing ambient room air.
BEHAVIORALTask 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.
OTHERSham 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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and assessors will be blinded to group allocation.
Intervention model description
The pilot study will utilize a double-blind, placebo-controlled, randomized-order, repeated-measures, cross-over experimental design
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of laryngeal vestibule closure (dLVC) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penetration-Aspiration Scale Scores | 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). |
Countries
United States
Outcome results
None listed