Research Study Targets Breathing Function after Spinal Cord Injury

Fluctuating Oxygen [FLO2] for Recovery after SCI

This study (IRB201802672) is a $2.4 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 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.

This study will determine if a new strategy, acute intermittent hypoxia, combined with respiratory strength training will promote greater and more sustainable gains in respiratory function than either intervention alone.

What is acute intermittent hypoxia?

When Less Oxygen Heals

Novel treatment for spinal cord injury put to the test

Photo of animation of how Intermitten Hypoxia works Play Video

Acute intermittent hypoxia is a promising approach to improving function after a spinal cord injury, including breathing function. Acute intermittent hypoxia (i.e., fluctuating oxygen) 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 acute intermittent hypoxia with respiratory strength training, a well-known intervention that consists of breathing against resistance through a simple, hand-held device. 

Clinicians demonstrate intermittent hypoxia therapy.

Is it safe?

Yes. Many studies have shown that both acute intermittent hypoxia and respiratory strength training are safe and can be delivered without unwanted side effects. We also will help ensure all procedures are comfortable and will answer any question you may have. 

What does participation in the FLO2 study involve?

Study participation involves 4 interventions involving acute intermittent hypoxia and respiratory strength training. Each intervention involves 5 daily treatment sessions.

  • 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.
flow chart of study schedule. After your initial screening and eligibility in Month 1, in week 1 you have a pre-test, training sessions, post test and day 1 assessment. In week 2, you have a day 3 and day 7 assessment. In week 3 and 4 you have no visits. This schedule is repeated in Months 2, 3 and 4. The timing of visits may be slightly adjusted.

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
  • SCI > 1 year 
  • Injury level C-1 to T-12
  • Otherwise healthy 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 $30-$50 depending on the duration of the visit. A total of $1,320 may be provided for completion of all study visits. Additional support may be provided for reimbursement of travel related expenses. 

Clinicians demonstrate intermittent hypoxia therapy.

Contact the Team

Be a part of a study that harnesses acute intermittent hypoxia and respiratory training to improve breathing function after spinal cord injury.

Principal Investigators

PREEMINENT PROFESSOR OF NEUROSCIENCE

Gordon Mitchell, PhD

Gordon Mitchell

RESEARCH ASSociate PROFESSOR, BROOKS REHABILITATION RESEARCH SCIENTIST

Emily Fox, PT, DPT, PhD, NCS

Emily Fox