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

N/ACompletedNCT06520358

University of Florida5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

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 TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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