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Completed

NCT Number: NCT06520358

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

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Trauma, Nervous System Wounds and Injuries

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Training

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.

Other names: volitional laryngeal vestibule closure (vLVC) training

Sham AIH

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.

Primary outcomes

  1. Duration of laryngeal vestibule closure (dLVC)

    Time frame: Pre-intervention, 1 day after intervention block and 1-week post intervention

    Time in (msec) the laryngeal vestibule stays closed during a swallow

  2. Time to laryngeal vestibule closure (Time-to-LVC)

    Time frame: 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 outcomes

  1. Penetration-Aspiration Scale Scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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