Spinal Cord InjuriesNCT06011876
BioFLO for Respiratory Recovery in SCI
A study testing Acute Intermittent Hypoxia (AIH) and Acute Intermittent Hypercapnic-Hypoxia (AIHH) in people with Spinal Cord Injuries, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Acute Intermittent Hypoxia (AIH) and Acute Intermittent Hypercapnic-Hypoxia (AIHH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 neuropathic pain
- Known pregnancy
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooks Rehabilitation
Jacksonville, Florida, 32216
Emily J. Fox, MHS, DPT, PhD, (904) 742-2500, ejfox@phhp.ufl.edu
About this study
Official title: Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI
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.
Read the detailed description
This study will consist of two parts - single-session testing days, and respiratory strength training blocks. If a participant is not eligible to enroll in single-day testing, they will be asked to enroll in only the respiratory strength training blocks.
On single-session testing days, participants will be asked to come in on three separate days they will complete a battery of tests, then be given one of three interventions, and then complete the same battery of tests. The three interventions are acute intermittent hypoxia (AIH), acute intermittent hypercapnic-hypoxia (AIHH), or sham acute intermittent hypoxia (sham AIH). These interventions are explained in more detail below.
During respiratory strength training blocks, participants will receive five days of AIH, AIHH, or sham AIH in combination with respiratory strength training, which uses small hand-held devices to strengthen the muscles used for breathing. Participants will be asked to complete all three blocks to receive all three interventions. In addition to 5 days of interventions and respiratory strength training, the respiratory strength training blocks include testing 1 day, 3 days, and 7 days after the 5 days of respiratory strength training.
- Conditions
- Spinal Cord Injuries
- Being tested
- Acute Intermittent Hypoxia (AIH), Acute Intermittent Hypercapnic-Hypoxia (AIHH), Sham AIH
- Keywords
- acute intermittent hypoxia, spinal cord injury, breathing, motor function
- Medical subject headings
- Spinal Cord Injuries, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AIHOther
A single session of sham AIH with episodes of normal room air (21% O2).
| Study group | Role | What they receive |
|---|---|---|
| Single-session testing days | Experimental | 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. Receives: Other: Acute Intermittent Hypoxia (AIH); Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH); Other: Sham AIH |
| Respiratory strength training blocks | Experimental | 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. Receives: Other: Acute Intermittent Hypoxia (AIH); Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH); Other: Sham AIH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor evoked potential
The change in peak-to-peak amplitude of the motor evoked potential of the diaphragm will be tested using transcranial magnetic stimulation.
Measured: Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day
Change in maximal inspiratory pressure
Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.
Measured: Baseline, 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.)
Change in maximal expiratory pressure
Maximal expiratory pressure is a non-invasive measure of the maximal force achieved when breathing out against an occluded airway.
Measured: Baseline, 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start21 Dec 2023
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Sponsor
- Investigators
- Emily Fox, DPT, MHS, PhD, Principal investigator, University of Florida & Brooks Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011876
- Sponsor's protocol ID
- IRB202202891
- Other IDs
- W81XWH2210478
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI
- ClinicalTrials.gov ID
- NCT06011876
- Acronym / sponsor ID
- IRB202202891
- Conditions
- Spinal Cord Injuries
- Keywords
- acute intermittent hypoxia, spinal cord injury, breathing, motor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will consist of two parts - single-session testing days, and respiratory strength training blocks. If a participant is not eligible to enroll in single-day testing, they will be asked to enroll in only the respiratory strength training blocks.
On single-session testing days, participants will be asked to come in on three separate days they will complete a battery of tests, then be given one of three interventions, and then complete the same battery of tests. The three interventions are acute intermittent hypoxia (AIH), acute intermittent hypercapnic-hypoxia (AIHH), or sham acute intermittent hypoxia (sham AIH). These interventions are explained in more detail below.
During respiratory strength training blocks, participants will receive five days of AIH, AIHH, or sham AIH in combination with respiratory strength training, which uses small hand-held devices to strengthen the muscles used for breathing. Participants will be asked to complete all three blocks to receive all three interventions. In addition to 5 days of interventions and respiratory strength training, the respiratory strength training blocks include testing 1 day, 3 days, and 7 days after the 5 days of respiratory strength training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-session testing days | Experimental | Other: Acute Intermittent Hypoxia (AIH), Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH), Other: Sham AIHParticipants 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. |
| Respiratory strength training blocks | Experimental | Other: Acute Intermittent Hypoxia (AIH), Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH), Other: Sham AIHParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 18-70 years of age
- Chronic incomplete SCI ≥ 1 year at or below C1-T12
- -OR- Chronic complete SCI ≥1 year at or below C4-T12
- Medically stable with physician clearance
- SCI due to non-progressive etiology
Key exclusion criteria (6 listed)
- 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 neuropathic pain
- Known pregnancy
- Severe recurrent autonomic dysreflexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent Hypoxia (AIH)AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2). | Other | Respiratory strength training blocks, Single-session testing days |
| Acute Intermittent Hypercapnic-Hypoxia (AIHH)AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2). | Other | Respiratory strength training blocks, Single-session testing days |
| Sham AIHA single session of sham AIH with episodes of normal room air (21% O2). | Other | Respiratory strength training blocks, Single-session testing days |
Primary outcome
Change in motor evoked potential
Time frame: Baseline, 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 pressure
Time frame: Baseline, 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 pressure
Time frame: Baseline, 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Fox, DPT, MHS, PhD principal investigator
University of Florida & Brooks Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) and Acute Intermittent Hypercapnic-Hypoxia (AIHH) in people with Spinal Cord Injuries, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily J Fox, PT, MHS, PhD (904-742-2500, ejfox@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor evoked potential (time frame: Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.