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Recruiting EARLY_Phase 1 NCT05467215

Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?

Trial Parameters

Condition Spinal Cord Injuries
Sponsor University of Alberta
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 25
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2022-07-11
Completion 2026-12-31
Interventions
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408

Brief Summary

This proof-of-principle study will determine if breathing an increased concentration of oxygen above the concentration in normal room air results in changes in the sensory and motor function in people with subacute or chronic, severe spinal cord injury (SCI).

Eligibility Criteria

Inclusion Criteria: 1. Individuals with traumatic SCI with onset ≥3 months prior, 2. Between 18 - 65 yr old, 3. ASIA Impairment Scale at discharge classified as A, B or C, 4. Injury level between C5 and T10, 5. Able to give informed, written consent. Exclusion Criteria: 1. Frequent uncontrolled autonomic dysreflexia, 2. Uncontrolled high blood pressure, 3. Cardiac or cardiovascular disease, 4. Cancer, 5. Active urinary tract infection, 6. Active pressure sores, 7. Signs of deep vein thrombosis in the legs, 8. Severe swelling of the feet and/or legs, 9. Severe cognitive impairment, 10. Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection, 11. Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain 12. Pregnancy.

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