RECRUITING Not applicable ClinicalTrials.gov

BioFLO for Respiratory Recovery in SCI

Sponsor: University of Florida • ClinicalTrials.gov ID: NCT06011876

Registry updated: 2026-09-14

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Description

Acute intermittent hypoxia (AIH) involves brief (1 min), repeated episodes (\~15) of breathing low oxygen air to stimulate spinal neuroplasticity. Animal and human studies show that AIH improves motor function after spinal cord injury, particularly with slightly increased carbon dioxide (hypercapnic AIH; AIHH) and task-specific training. Using a double blind cross-over design, the study will test whether AIHH improves breathing more than AIH and whether specific genetic variations are related to individuals' intervention responses.

Interventions

Acute Intermittent Hypoxia (AIH) (Other)
AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).
Acute Intermittent Hypercapnic-Hypoxia (AIHH) (Other)
AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).
Sham AIH (Other)
A single session of sham AIH with episodes of normal room air (21% O2).

Eligibility criteria

Inclusion Criteria: 1. Adults 18-70 years of age 2. Chronic incomplete SCI ≥ 1 year at or below C1-T12 * 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 Exclusion Criteria: 1. Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury 2. Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension 3. Severe neuropathic pain 4. Known pregnancy 5. Severe recurrent autonomic dysreflexia Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold.

Conditions

Spinal Cord Injuries

Locations

Brooks Rehabilitation — Jacksonville, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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