Clinical trial NCT06520358: Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
Official title: Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: acute intermittent hypoxia
rehabilitation
airway protection
dysphagia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The pilot study will utilize a double-blind, placebo-controlled, randomized-order, repeated-measures, cross-over experimental design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of laryngeal vestibule closure (dLVC)
timeFrame: Pre-intervention, 1 day after intervention block and 1-week post intervention
measure: Time to laryngeal vestibule closure (Time-to-LVC)
timeFrame: Pre-intervention, 1 day after intervention block and 1-week post intervention
Secondary outcomes:
measure: Penetration-Aspiration Scale Scores
timeFrame: Pre-intervention, 1 day after intervention block and 1-week post intervention
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Alicia Z Vose, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Welch 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.
citation: Vose 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.