Rehabilitation for Breathing Support
(REHAB-MV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this research study is to evaluate the effects of a single session of rehabilitation in healthy adults, before noninvasive mechanical ventilation (MV). MV can help support breathing function during sleep or illness. High levels of MV support have been reported to alter the function of the diaphragm muscle, the primary breathing muscle, in people with compromised health. However, rehabilitation may have some potential to improve diaphragm function in advance of using MV. This study will test different rehabilitation interventions, including (1) inspiratory strength training (IST), (2) transcutaneous spinal cord stimulation (TSCS), or sham TSCS. Before and after MV, participants will complete breathing strength tests and responses to phrenic nerve stimulation.
Who Is on the Research Team?
Barbara K Smith, PhD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Familiarization
Participants complete a familiarization session to understand the procedures and interventions
Treatment
Participants undergo three separate, two-hour noninvasive MV sessions, each preceded by a different intervention: high-intensity IST, transcutaneous spinal cord stimulation, or sham stimulation
Follow-up
Participants are monitored for changes in respiratory drive, diaphragm strength, and dyspnea up to 24 hours post-MV
What Are the Treatments Tested in This Trial?
Interventions
- Inspiratory Strength Training
- Sham Stimulation
- Spinal cord stimulation
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
5 sets of 5 breaths of high-intensity inspiratory strength training
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
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