NCT05467215 Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
| NCT ID | NCT05467215 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Alberta |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2022-07-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jaynie Yang
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05467215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05467215 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05467215 currently recruiting?
Yes, NCT05467215 is actively recruiting participants. Contact the research team at carre@ualberta.ca for enrollment information.
Where is the NCT05467215 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05467215 clinical trial?
NCT05467215 is sponsored by University of Alberta. The principal investigator is Jaynie Yang at University of Alberta. The trial plans to enroll 25 participants.