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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Florida
RECRUITING
Jacksonville
Contact Information
Primary
Alicia Vose, Ph.D.
Alicia.Vose@jax.ufl.edu
904-244-9092
Backup
Maribel Z Ciampitti, M.S.
maribel.ciampitti@jax.ufl.edu
904-244-4674
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 5
Treatments
Active_comparator: 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.
Sham_comparator: 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.
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov