BioFLO: Biomarkers of respiratory recovery after fluctuating oxygen in SCI
This study (IRB202202891) is a $3.6 million study funded by the Department of Defense and is underway at Brooks Rehabilitation in Jacksonville, FL. The study is part of a collaborative effort involving the Brooks/UF-PHHP Research Collaboration in conjunction with the UF Center for Respiratory Research and Rehabilitation. Our goal is to bring together experts, innovations in research, and clinical care to improve patient outcomes.
What is the purpose of this study?
What is acute intermittent hypercapnic hypoxia (AIHH)?
What does participation in the BioFLO study look like?
Is it safe?
Do I qualify?
Is compensation provided?
What is the purpose of this research study?
Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, causing decreased breathing function. Respiratory impairments after SCI can often lead to serious illnesses such as pneumonia and chronic infections, re-hospitalization, and even death.
The purpose of this study is to optimize therapeutic intermittent hypercapnic hypoxia (fluctuating O2/CO2) as a treatment to improve breathing in persons with SCI.
What is acute intermittent hypercapnic hypoxia?
Acute intermittent hypercapnic hypoxia is a promising approach to improving function after a spinal cord injury, including breathing function. Acute intermittent hypercapnic hypoxia (i.e., fluctuating oxygen and CO2) consists of short periods (1-2 minutes) of breathing low oxygen air, alternated with breathing normal room air (1-2 minutes). This study will combine stimulating and recording the activity of breathing muscles as well as measuring breathing before and after therapeutic intermittent hypercapnic hypoxia treatments.
What does participation in the BioFLO study involve?
Study participation involves two parts.
The first part of the study will have participants complete a sleep characterization study and provide a saliva sample. Participants will then compete 3, 5-day intervention blocks. Assessments will be conducted before and after each 5-day intervention. To determine how long the intervention effects last, we will conduct assessments 1 day, 3 days, and 7 days after each intervention.
During the second part of the study, participants will complete 3, 1-day sessions using transcranial magnetic stimulation. These 1-day sessions will have a week in between each session.
Is it safe?
All studies investigating acute intermittent hypercapnic hypoxia have shown that it can be safe and delivered without unwanted side effects. Many more studies have also shown that acute intermittent hypoxia (fluctuating oxygen only) combined with constant hypercapnia (increased, non-fluctuating carbon dioxide through the whole protocol) is safe and well-tolerated. We will also help ensure all procedures are comfortable and will answer any questions you may have.
Do I qualify?
We conduct a multi-step screening process to verify that study participation will be safe and potentially beneficial for each individual. Eligibility criteria include:
- Adults 18-70 years old
- Chronic SCI for ≥1 year
- Injury level C-1 to T-12
- Medically stable with physician clearance
- Other eligibility criteria will apply
Is compensation provided?
Yes, compensation is provided for study participation. Participants will be compensated for each study visit and paid on a regular basis during their participation. Payments per visit are $40-95 depending on the duration of the visit. A total of $1,575 may be provided for completion of all study visits. Additional support may be provided for reimbursement of travel related expenses.
Contact the Team
Be a part of a study that harnesses acute intermittent hypercapnic hypoxia and respiratory training to improve breathing function after spinal cord injury.
Principal Investigators
Preeminent professor of Neuroscience
Gordon Mitchell, PhD
Research Associate Professor, Brooks Rehabilitation Research Scientist, Brooks/UF-PHHP Research Collaboration Director
Emily Fox, PT, DPT, PhD, NCS
