Short low-oxygen breathing sessions to help early breathing recovery after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.