Low-oxygen breathing sessions, genes and breathing after spinal cord injury
Tests low-oxygen breathing sessions in people with spinal cord injury.
Key facts
- Who runs it
- University of Florida
- Where
- Jacksonville, United StatesSee the site
- Trial code
- Registry title
- BioFLO for Respiratory Recovery in SCI
- Status
- Recruiting
- People taking part
- 62 people, planned
- Started
- 21 Dec 2023
- Expected to end
- Sept 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Acute Intermittent Hypoxia (AIH)
- Acute Intermittent Hypercapnic-Hypoxia (AIHH)
- Sham AIH
- Record updated
- 14 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a long-term spinal cord injury and weak breathing muscles. It tests short periods of breathing low-oxygen air to improve breathing.
- Age
- 18 to 70 years
- Sex
- All sexes
- Disease stage
- Chronic spinal cord injury for at least 1 year. Incomplete injury at or below C1-T12 (ASIA grade B, C or D), or complete injury at or below C4-T12 (ASIA grade A). The injury must not be getting worse over time. People must be medically stable, with a doctor's approval.
- Biomarker or test result
- Breathing-in or breathing-out pressure (or both) must be 20% weaker than normal values.
Main reasons for not taking part
- Another nerve or brain condition, such as Multiple Sclerosis, Parkinson disease, stroke or brain injury
- Severe illness or infection, such as non-healing pressure sores, untreated urinary infections, heart or lung disease, or uncontrolled high blood pressure
- Severe nerve pain
- Known pregnancy
- Severe repeated autonomic dysreflexia (sudden dangerous rises in blood pressure)
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Adults 18-70 years of age
- 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
- Medically stable with physician clearance
- SCI due to non-progressive etiology
- 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values
Who cannot take part
- Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
- 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
- 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
- Severe neuropathic pain
- Known pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- Brooks RehabilitationJacksonville, United StatesContact: Emily J. Fox, MHS, DPT, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Single-session testing daysTreatment being tested
Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive AIH, AIHH, and sham AIH in random order. Post-testing will occur after each intervention.
Treatment: Acute Intermittent Hypoxia (AIH), Acute Intermittent Hypercapnic-Hypoxia (AIHH), and Sham AIH
- Respiratory strength training blocksTreatment being tested
Participants will complete three separate respiratory strength training blocks. In each block, participants will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Each block will include 5 days of intervention and training, and post-testing 1, 3, and 7 days after intervention and training has concluded.
Treatment: Acute Intermittent Hypoxia (AIH), Acute Intermittent Hypercapnic-Hypoxia (AIHH), and Sham AIH
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI
- Plain-language title
- Low-oxygen breathing sessions, genes and breathing after spinal cord injuryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06011876, who can take part
- Record updated
- 14 September 2026