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Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

Not Applicable
Completed
Conditions
Spinal Cord Injuries
Interventions
Device: Hypoxia via Hypoxico Hyp-123
Device: Sham via Hypoxico Hyp-123
Registration Number
NCT03071393
Lead Sponsor
University of Florida
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Acute Intermittent Hypoxia, then Sham Intermittent HypoxiaSham via Hypoxico Hyp-123Subjects 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).
Sham Intermittent Hypoxia, then Acute Intermittent HypoxiaSham via Hypoxico Hyp-123Subjects 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).
Acute Intermittent Hypoxia, then Sham Intermittent HypoxiaHypoxia via Hypoxico Hyp-123Subjects 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).
Sham Intermittent Hypoxia, then Acute Intermittent HypoxiaHypoxia via Hypoxico Hyp-123Subjects 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).
Primary Outcome Measures
NameTimeMethod
Change in Forced Vital CapacityChange 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 in Maximal Expiratory PressureChange between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of expiratory muscle strength.

Change in Maximal Inspiratory PressureChange between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of inspiratory muscle strength.

Change in Mouth Occlusion Pressure (P0.1)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

University of Florida

🇺🇸

Gainesville, Florida, United States

Brooks Rehabilitation

🇺🇸

Jacksonville, Florida, United States

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