An interventional study of Hypoxia via Hypoxico Hyp-123 and Sham via Hypoxico Hyp-123 in Spinal Cord Injuries, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's enrollment of 17 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Exclusion criteria:
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 · Device: Sham via Hypoxico Hyp-123
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 · Device: Sham 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.
Also known as: Altitude Generator
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.
Also known as: Altitude Generator
Change in Maximal Inspiratory Pressure
An assessment of inspiratory muscle strength.
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Maximal Expiratory Pressure
An assessment of expiratory muscle strength.
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Forced Vital Capacity
An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Mouth Occlusion Pressure (P0.1)
An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Individuals were recruited through advertisements and rehabilitation health facilities in north Florida. Recruitment occurred from 07/2017 through 12/2019.
| Milestone | Acute Intermittent Hypoxia, Then Sham Intermittent Hypoxia | Sham Intermittent Hypoxia, Then Acute Intermittent Hypoxia |
|---|---|---|
| Started | 7 | 10 |
| Completed | 7 | 10 |
| Not completed | 0 | 0 |
| Milestone | Acute Intermittent Hypoxia, Then Sham Intermittent Hypoxia | Sham Intermittent Hypoxia, Then Acute Intermittent Hypoxia |
|---|---|---|
| Started | 7 | 10 |
| Completed | 7 | 10 |
| Not completed | 0 | 0 |
| Milestone | Acute Intermittent Hypoxia, Then Sham Intermittent Hypoxia | Sham Intermittent Hypoxia, Then Acute Intermittent Hypoxia |
|---|---|---|
| Started | 7 | 10 |
| Completed | 7 | 10 |
| Not completed | 0 | 0 |
An assessment of inspiratory muscle strength.
| cmH2O | All Study Participants - Acute Intermittent Hypoxia | All Study Participants - Sham |
|---|---|---|
| Change in Maximal Inspiratory Pressure | 8.2 ± 12.3 | -3.0 ± 11.3 |
An assessment of expiratory muscle strength.
| cmH2O | All Study Participants - Acute Intermittent Hypoxia | All Study Participants - Sham |
|---|---|---|
| Change in Maximal Expiratory Pressure | 4.3 ± 11.5 | 2.9 ± 9.8 |
An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.
| Liters | All Study Participants - Acute Intermittent Hypoxia | All Study Participants - Sham |
|---|---|---|
| Change in Forced Vital Capacity | -0.01 ± 0.17 | 0.00 ± 0.21 |
An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.
| cmH2O | All Study Participants - Acute Intermittent Hypoxia | All Study Participants - Sham |
|---|---|---|
| Change in Mouth Occlusion Pressure (P0.1) | 0.24 ± 0.30 | 0.15 ± 0.50 |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acute Intermittent Hypoxia | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Sham Intermittent Hypoxia | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 34.1 ± 14.5 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 13 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 17 |
| ASIA Impairment Scale(Participants) | All Study Participants |
|---|---|
| AIS A Complete SCI | 6 |
| AIS B motor complete SCI | 7 |
| AIS C motor incomplete | 3 |
| AIS D motor incomplete | 1 |
| Spinal Cord Injury chronicity(months) | All Study Participants |
|---|---|
| Mean | 63.1 ± 112.9 |
| Upper Extremity Motor Score (UEMS)(units on a scale) | All Study Participants |
|---|---|
| Mean | 40.2 ± 15.3 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2017 to primary completion in Sep 2020, 37 months.
Results were first posted in Nov 2023, 3 years 2 months after primary completion.
Of 766 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's 37 months is close to that.
Counting every sponsor, half of 816 studies reached it within 35 months; a quarter within 16 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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