Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

October 27, 2023 updated by: University of Florida

Acute 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Jacksonville, Florida, United States, 32216
        • Brooks Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

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

Exclusion criteria:

  1. 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
  2. Severe, untreated bladder or urinary tract infection
  3. Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
  4. Women who report being pregnant or test positive on a pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia
Subjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen).
Device: Hypoxia via Hypoxico Hyp-123
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
Device: Sham via Hypoxico Hyp-123
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
Experimental: Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia
Subjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen).
Device: Hypoxia via Hypoxico Hyp-123
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
Device: Sham via Hypoxico Hyp-123
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maximal Inspiratory Pressure
Time Frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
An assessment of inspiratory muscle strength.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Maximal Expiratory Pressure
Time Frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
An assessment of expiratory muscle strength.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
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.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
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.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography (EMG) of trunk and accessory respiratory muscles.
Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
Activation and timing of activation of trunk and other accessory respiratory muscles will be measured using EMG, which are small sensors that attach to the skin.
Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
Trunk and hip angles and position during assessments
Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
Electrogoniometers, sensors used to calculate joint angles, may be placed on the hips or the trunk to allow for measurement of the angle of those segments during each assessment task.
Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
Timed Up and Go test
Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
An assessment of walking balance and fall risk based on the participant's ability to stand up from a seated position, walk 10 meters, turn around, return to their chair and sit down. This test will only be performed by subjects who can safely attempt it.
Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
10 Meter Walk test
Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
An assessment of walking speed over a distance of 10 meters. This test will only be performed by subjects who can safely attempt it.
Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
30 Second Chair Stand test
Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham.
An assessment of lower body strength and power which evaluates the maximum amount of times that a participant can safely stand up from a seated position and sit back down. This test will only be performed by subjects who can safely attempt it.
Change between baseline- and 30 minutes post-intermittent hypoxia or sham.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Emily J Fox, MHS, DPT, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 6, 2017

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201601680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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