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Hyperoxia for Spinal Cord Injury
Phase < 1
Recruiting
Led By Jaynie Yang
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ASIA Impairment Scale at discharge classified as A, B or C
Injury level between C5 and T10
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after intervention (exposure to room air)
Awards & highlights
Study Summary
This trial will test if higher levels of oxygen improve movement and sensation in people with spinal cord injuries.
Who is the study for?
This trial is for adults aged 18-65 with severe spinal cord injuries between C5 and T10, which occurred at least 3 months ago. Participants must have an ASIA Impairment Scale rating of A, B, or C at discharge and be able to consent. It's not suitable for those with conditions worsened by remaining still for long periods, UTIs, cognitive impairments, cancer, pressure sores, uncontrolled autonomic dysreflexia or blood pressure issues.Check my eligibility
What is being tested?
The study tests if breathing pure oxygen (99%) can improve sensory and motor functions in individuals with chronic severe spinal cord injury. The oxygen used is from Praxair (DIN# 02014408), and the goal is to see if hyperoxia leads to functional changes compared to normal air concentration.See study design
What are the potential side effects?
While specific side effects are not listed for this trial of hyperoxia exposure in SCI patients, generally potential risks may include lung damage due to high oxygen levels over time or temporary visual changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury severity is classified as A, B, or C.
Select...
My spinal cord injury is between my neck and mid-back.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after intervention (exposure to room air)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after intervention (exposure to room air)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skin Sensation
Secondary outcome measures
Reflex Excitability
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hyperoxia followed by room airExperimental Treatment1 Intervention
Group 1 will receive oxygen (99%) in Phase 1, and room air (placebo) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. In Phase 2, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. Both high oxygen and room air will be delivered through a face mask. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure. In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.
Group II: Room air followed by hyperoxiaPlacebo Group1 Intervention
Group 2 will receive room air (placebo) in Phase 1, and oxygen (99%) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. In Phase 2, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. Both high oxygen and room air will be delivered through a face mask approved by Health Canada. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure.In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,109 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,542 Total Patients Enrolled
Jaynie YangPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
56 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can sit or lie down for 2 hours without worsening any condition like low back pain.I have lung problems like COPD or a recent lung infection.My high blood pressure is not under control.I currently have a urinary tract infection.My spinal cord injury severity is classified as A, B, or C.I often have sudden and severe high blood pressure.My spinal cord injury is between my neck and mid-back.I have significant memory or thinking problems.I have cancer.I have active pressure sores.I have had a spinal cord injury for more than 3 months.I have heart or blood vessel disease.I have severe swelling in my feet or legs.I have signs of a blood clot in my leg.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Room air followed by hyperoxia
- Group 2: Hyperoxia followed by room air
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there age-related constraints on joining this research?
"This trial is open to individuals aged 18 and up, but under 65."
Answered by AI
How many volunteers are currently enrolled in this clinical trial?
"Indeed, current information on clinicaltrials.gov suggests that this medicinal investigation is still enrolling people in its trial. This examination was initially posted on July 11th 2022 and has since been updated as of the 25th of July 2022. They are searching for 25 individuals from a single centre to participate."
Answered by AI
To whom is enrollment in this study open?
"To quality to this medical trial, applicants must have suffered a spinal cord injury and be within the age bracket of 18-65. This study is looking for around 25 participants."
Answered by AI
Are there any remaining openings for participants in this experiment?
"Yes, clinicaltrials.gov confirms that this study is actively recruiting participants as of July 25th 2022 - the date in which it was last updated. The experiment first began on 11 July and requires a total of 25 patients at one specific site."
Answered by AI
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