Using low oxygen exposure to improve airway protection in brain injury patients
Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
This study is testing if breathing low oxygen for short periods, along with special training, can help people with mild to moderate brain injuries improve their airway protection and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06520358 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of acute intermittent hypoxia (AIH) combined with task-specific airway protection training on individuals with chronic mild to moderate traumatic brain injury (TBI). Participants will undergo brief episodes of low oxygen breathing to stimulate neuroplasticity, which may enhance their rehabilitation outcomes. The study employs a double-blind cross-over design to compare the effectiveness of AIH plus training against training alone. The goal is to determine if this combined approach leads to better airway protection and overall recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-80 with a mild to moderate traumatic brain injury and a Glasgow Coma Scale score between 9-15.
Not a fit: Patients with severe neurological disorders, significant psychiatric conditions, or pre-existing pulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve airway protection and rehabilitation outcomes for patients with chronic traumatic brain injury.
How similar studies have performed: Previous studies have shown promising results with acute intermittent hypoxia in enhancing motor function after neural injury, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- University of Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Alicia Z Vose, Ph.D. — University of Florida
- Study coordinator: Alicia Vose, Ph.D.
- Email: Alicia.Vose@jax.ufl.edu
- Phone: 904-244-9092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.