Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

Drug
General health
Online since 4 November 2021, updated 887 days ago

About this trial

This is a clinical study enrolling individuals with chronic incomplete cervical (neck area) spinal cord injuries to test the effect of a breathing intervention called acute intermittent hypoxia (AIH). AIH provides air with low oxygen content for brief periods, alternating with room air with normal oxygen content. The study will compare the effect of AIH in individuals with and without obstructive sleep apnea (OSA, an abnormal breathing condition while sleeping). The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function — e.g., does moderate to severe OSA decrease the breathing and motor strength response to AIH. All participants will do a 3-day AIH protocol (5 and 90 second hypoxic intervals alternating with 60-second room air intervals). One group will include participants with OSA; the other group includes participants that do not have sleep apnea. Outcomes will be assessed on breathing function (inspiration and expiration) as well as on grip strength. Blood will be collected to measure changes in markers for intermittent hypoxia.

Included participants

Gender
All
Age
18 - 99 years
Injury level
C5 - C8
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 99 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C5-C8
    Additionally, participants must
    NOT be currently hospitalized
    have resting heart rate ≥120 beats per minute, or resting systolic blood pressure >180 mmHg,

    What’s involved

    Type

    Drug

    Details

    Three consecutive days of acute intermittent hypoxia sessions done with a face mask Five visits throughout the following 17 days Assessments of breathing function and strength Blood sampling for the investigation of blood markers

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    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
    • 16 Jul 2021
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 16 Jul 2021
    • Organisation
    • University of Miami

    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