N/A
Completed N=17
Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT03071393 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Change in Maximal Inspiratory Pressure — 8.2; -3.0 cmH2O — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maximal Inspiratory Pressure |
8.2; -3.0 | <0.05 sig |
| PRIMARY Change in Maximal Expiratory Pressure |
4.3; 2.9 | <0.05 sig |
| PRIMARY Change in Forced Vital Capacity |
-0.01; 0.00 | <0.05 sig |
| PRIMARY Change in Mouth Occlusion Pressure (P0.1) |
0.24; 0.15 | <0.05 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03071393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.