NCT06011876
BioFLO for Respiratory Recovery in SCI
Recruiting
NAAges 18–70InterventionalTreatmentUniversity of FloridaInvestigator-initiated
~62 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Acute Intermittent Hypoxia (AIH)Acute Intermittent Hypercapnic-Hypoxia (AIHH)Sham AIH
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in motor evoked potential
Measured over Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Emily Fox, DPT, MHS, PhD · PRINCIPAL_INVESTIGATOR · University of Florida & Brooks Rehabilitation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Incomplete SCI based on residual sensory and motor function below the level of the injury or injury classification of B, C, D at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.
OR- Chronic complete SCI ≥1 year at or below C4-T12
Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI. 3. Medically stable with physician clearance 4. SCI due to non-progressive etiology 5. 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values
What this trial measures
- Change in motor evoked potentialBaseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day
The change in peak-to-peak amplitude of the motor evoked potential of the diaphragm will be tested using transcranial magnetic stimulation.
- Change in maximal inspiratory pressureBaseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.)
Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.
- Change in maximal expiratory pressureBaseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.)
Maximal expiratory pressure is a non-invasive measure of the maximal force achieved when breathing out against an occluded airway.