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Completed

NCT Number: NCT03071393

Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.

Spinal cord injury affects the muscles that control respiration. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.

This study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, ages 18-65
  • Greater than 6 months post-spinal cord injury
  • Spinal cord injury affecting segments between C4-T12
  • No other known neurological disorders
  • Able to provide informed consent
  • no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.

Exclusion criteria

  • Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
  • Severe, untreated bladder or urinary tract infection
  • Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
  • Women who report being pregnant or test positive on a pregnancy test

Treatment and study plan

Hypoxia via Hypoxico Hyp-123

Device

During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.

Other names: Altitude Generator

Sham via Hypoxico Hyp-123

Device

During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.

Other names: Altitude Generator

Primary outcomes

  1. Change in Maximal Inspiratory Pressure

    Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

    An assessment of inspiratory muscle strength.

  2. Change in Maximal Expiratory Pressure

    Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

    An assessment of expiratory muscle strength.

  3. Change in Forced Vital Capacity

    Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

    An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.

  4. Change in Mouth Occlusion Pressure (P0.1)

    Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

    An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2017
Registry last updated
Nov 18, 2023

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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