BioFLO for Respiratory Recovery in SCI

Drug
General health
Online since 19 March 2024, updated 93 days ago

About this trial

This trial is enrolling 62 individuals with chronic, incomplete spinal cord injuries to test the effect of two types of acute intermittent hypoxia (AIH and AIHH) on breathing function. AIH involves brief, repeated episodes of breathing low oxygen air; AIHH includes repeated episodes of low oxygen and elevated carbon dioxide. Intermittent hypoxia has been shown to stimulate spinal nerve growth (plasticity). If included, participants will complete either 3 single-session testing days; or 3 respiratory strength training blocks. The first group will then complete 3 testing days, receiving AIH, AIHH, and sham AIH in random order each day. The second group will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Investigators want to see if AIHH improves breathing more than AIH. Final testing of respiration will be performed 7 days after the intervention.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C3 - T12
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C3-T12
    Additionally, participants must
    have an SCI due to non-progressive etiology
    NOT have a cardiac pacemaker
    NOT have metal implants in the skull

    What’s involved

    Type

    Drug

    Details

    - Participants will complete either 1) 3 single-session testing days or 2) 3 respiratory strength training blocks. - The first group will complete 3 testing days, receiving AIH, AIHH, and sham AIH in random order each day. - The second group will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. - AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2). - AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2). - A single session of sham AIH with episodes of normal room air (21% O2). - Testing will occur 1, 3, and 7 days after intervention.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 21 Dec 2023
    • Organisation
    • University of Florida
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 21 Dec 2023
    • Organisation
    • University of Florida

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more