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NCT Number: NCT06011876

BioFLO for Respiratory Recovery in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location status: Recruiting

Location contact

Emily J. Fox, MHS, DPT, PhD

CONTACT

[email protected]

(904) 742-2500

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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 AIH

Other

A single session of sham AIH with episodes of normal room air (21% O2).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily J Fox, PT, MHS, PhD

CONTACT

[email protected]

904-742-2500

Hannah Snyder, M.S.

CONTACT

[email protected]

904-345-6910

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • U.S. Army Medical Research Acquisition Activity

Registry information

Official study title

Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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