Taking people in United StatesNo phase

Breathing low-oxygen air to help breathing after recent spinal cord injury

Compares two low-oxygen breathing methods in adults with recent spinal cord injury.

Key facts

Who runs it: University of Florida
Where: Jacksonville, United StatesSee the site
Trial code: NCT07002437
Registry title: Hypoxia Pathways for Early Recovery After Spinal Cord Injury
Status: Recruiting
People taking part: 18 people, planned
Started: 20 Nov 2025
Expected to end: Jul 2027
Type of study: Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested: Augmented Acute Intermittent Hypoxia (aAIH)
Acute Intermittent Hypercapnic-Hypoxia (AIHH)
Sham AIH
Record updated: 3 December 2025

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 recent spinal cord injury, 2 weeks to 6 months after the injury. It compares two breathing treatments that use short periods of low oxygen.

Age: 18 to 70 years
Sex: All sexes
Disease stage: Spinal cord injury 2 weeks to 6 months after injury, from a cause that does not get worse over time. Incomplete injury at or below C1-T6 (grade B, C or D), or complete injury at or below C4-T6 (grade A). People must be medically stable, with a doctor's approval.

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 bladder infections, heart disease, lung disease or uncontrolled high blood pressure
Severe nerve pain or severe uncontrolled autonomic dysreflexia (sudden dangerous rises in blood pressure)
Known pregnancy
Currently staying in an acute care hospital

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

Adults 18-70 years of age
Sub-acute incomplete SCI 2 weeks to 6 months after injury, at or below C1-T6 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- Sub-acute complete SCI 2 weeks to 6 months after injury at or below C4-T6 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

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 neuropathic pain
Known pregnancy
Severe uncontrolled autonomic dysreflexia
Currently hospitalized in an acute care hospital

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: Hannah J SnyderTaking people

About the trial

What the trial wants to find out

Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, diminishing breathing capacity and airway defense (e.g., cough). Indeed, respiratory impairment is a leading cause of infection, re-hospitalization and death after SCI. There is a critical need for new strategies to restore breathing ability and airway defense in people with SCI. Acute intermittent hypoxia (AIH) - repetitive exposure to brief episodes of low inspired oxygen - is a promising strategy to restore breathing capacity by promoting spinal neuroplasticity. Exciting outcomes in >12 SCI trials completed to date demonstrate that AIH improves human respiratory and limb function. Unfortunately, ~40% of individuals exhibit minimal response to AIH, making it essential to 1) optimize AIH protocols to maximize functional benefits; and 2) identify genetic biomarkers distinguishing those most/least likely to benefit from AIH-based treatments.

Read full original descriptionShow less

The purpose of the pilot study, to be conducted in a small sample of participants with sub-acute SCI (2 weeks to 6 months post injury), is to preliminarily compare the effects of two intermittent hypoxia protocols. Since AIH-induced plasticity may be induced via serotonin or adenosine-driven mechanisms and these pathways compete and inhibit each other, each protocol favors a distinct mechanistic pathway. Our long-term objective is to test the hypothesis that a longer duration (i.e., augmented) hypoxia protocol, favoring adenosine mechanisms, enhances respiratory motor plasticity more than an AIH protocol targeting serotonin mechanisms (low O2 + CO2) in people with sub-acute SCI. Since an individual's genetics can influence the response to rehabilitation, we are also investigating how certain genes are related to breathing changes after these treatments.

Data acquired through this pilot study will be used to inform a larger, more definitive clinical trial and will contribute to estimations of the magnitude and direction of effects.

The 3 groups in the trial

ShamSham treatment, for comparison
Participants will complete a baseline testing session, 6 sessions of sham intervention (5, 3-minute episodes of 21% O2, 2-minute intervals), and post-test assessments 1-day and 1-week after the last intervention.
Treatment: Sham AIH
AIHHTreatment being tested
Participants will complete a baseline testing session, 6 sessions of acute intermittent hypercapnic hypoxia (AIHH) intervention (15, 1-minute episodes of 9-13% O2 + 4-5% CO2, 1.5-minute intervals), and post-test assessments 1-day and 1-week after the last intervention.
Treatment: Acute Intermittent Hypercapnic-Hypoxia (AIHH)
aAIHTreatment being tested
Participants will complete a baseline testing session, 6 sessions of augmented acute intermittent hypoxia (aAIH) intervention (3, 5-minute episodes of 9-13% O2, 3-minute intervals), and post-test assessments 1-day and 1-week after the last intervention.
Treatment: Augmented Acute Intermittent Hypoxia (aAIH)