Short low-oxygen breathing sessions to help early breathing recovery after spinal cord injury
Intermittent Hypoxia-Induced Motor Plasticity in Sub-Acute Spinal Cord Injury
NA · University of Florida · NCT07002437
This study will test whether two types of brief low-oxygen breathing sessions can improve breathing strength and airway defense in people 2 weeks to 6 months after a spinal cord injury.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07002437 on ClinicalTrials.gov |
What this trial studies
This pilot study will compare an augmented acute intermittent hypoxia protocol (aAIH: three 5-minute low-oxygen episodes per session) to an acute intermittent hypercapnic-hypoxia protocol (AIHH: multiple 1-minute low-oxygen plus CO2 episodes) and a sham condition in people with sub-acute spinal cord injury. Participants will undergo six treatment sessions and measurements of respiratory motor function before and after the interventions. Investigators will also collect genetic data to look for markers that predict who benefits from these breathing-based protocols. The goal is to gather preliminary effect-size and feasibility data to guide a larger definitive trial and to inform optimization of AIH-based rehabilitation.
Who should consider this trial
Good fit: Adults aged 18–70 with sub-acute spinal cord injury (2 weeks to 6 months post-injury) at specified cervical or thoracic levels who are medically stable and cleared by a physician are ideal candidates.
Not a fit: People with progressive neurologic diseases, unstable medical conditions, injuries outside the 2-week to 6-month window, or injuries outside the specified spinal levels are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, these breathing protocols could strengthen breathing and cough function, lowering the risk of respiratory infections and rehospitalization after spinal cord injury.
How similar studies have performed: More than a dozen prior human studies of acute intermittent hypoxia have reported improvements in respiratory and limb function after spinal cord injury, but many individuals show minimal response and protocol optimization and genetic predictors remain underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 18-70 years of age 2. 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. 3. Medically stable with physician clearance 4. SCI due to non-progressive etiology 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 uncontrolled autonomic dysreflexia 6. Currently hospitalized in an acute care hospital
Where this trial is running
Jacksonville, Florida
- Brooks Rehabilitation — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Emily J Fox, PT, DPT, MHS, PhD — University of Florida & Brooks Rehabilitation
- Study coordinator: Emily J Fox, PT, DPT, MHS, PhD
- Email: ejfox@phhp.ufl.edu
- Phone: 904-742-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Spinal Cord Injury, Intermittent Hypoxia, breathing, subacute, respiratory, acute intermittent hypoxia, hypoxia