Testing Pure oxygen (99%) from Praxair, against a placebo for spinal cord injuries
Official title: Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
- Early Phase 1
- 2 groups
- One site, in Edmonton
- Recruiting
Interventions
- Medication
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
Participants will receive oxygen (99%) or room air (placebo) delivered through a face mask at a flow rate of 10 litres/min for 2 minutes. The participants will be exposed twice to both conditions over 4 experiments at a minimum of 2 week intervals between each testing session.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Alberta, Clinical Sciences Bldg
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Between 18 - 65 yr old,
- +Individuals with traumatic SCI with onset ≥3 months prior,
- +ASIA Impairment Scale at discharge classified as A, B or C,
- +Injury level between C5 and T10,
- +Able to give informed, written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Frequent uncontrolled autonomic dysreflexia,
- −Uncontrolled high blood pressure,
- −Cardiac or cardiovascular disease,
- −Active urinary tract infection,
- −Active pressure sores,
- −Signs of deep vein thrombosis in the legs,
- −Severe swelling of the feet and/or legs,
- −Severe cognitive impairment,
- −Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection,
- −Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain
- −Pregnancy.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Early Phase 1Early Phase 1A very small, very early study of how the body handles a treatment.Read more → — the earliest human testing, in a very small group, to observe how the body handles it.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408.
Registry label: A: Hyperoxia followed by room air
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408.
Registry label: B: Room air followed by hyperoxia
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 25 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Pre-intervention (exposure to high oxygen).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Skin Sensation — measured over Pre-intervention (exposure to high oxygen).
Skin Sensation — measured over Immediately after intervention (exposure to high oxygen).
Skin Sensation — measured over Pre-intervention (exposure to room air).
Skin Sensation — measured over Immediately after intervention (exposure to room air).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05467215 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408Drug
Participants will receive oxygen (99%) or room air (placebo) delivered through a face mask at a flow rate of 10 litres/min for 2 minutes. The participants will be exposed twice to both conditions over 4 experiments at a minimum of 2 week intervals between each testing session.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Pre-intervention (exposure to high oxygen).
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 25 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.