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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-09-30

Brief Summary

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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).

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Detailed Description

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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

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The pilot study will utilize a double-blind, placebo-controlled, randomized-order, repeated-measures, cross-over experimental design

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and assessors will be blinded to group allocation.

Study Groups

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AIH + TST

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.

Group Type ACTIVE_COMPARATOR

Acute Intermittent Hypoxia (AIH)

Intervention Type 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 Training

Intervention Type BEHAVIORAL

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 AIH + TST

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.

Group Type SHAM_COMPARATOR

Task specific Airway Protection Training

Intervention Type BEHAVIORAL

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 AIH

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Task 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.

Intervention Type BEHAVIORAL

Sham 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.

Intervention Type OTHER

Other Intervention Names

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volitional laryngeal vestibule closure (vLVC) training

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No