Spinal Cord InjuriesEarly Phase 1NCT05467215
Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
A Early Phase 1 study testing Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 in people with Spinal Cord Injuries, run by University of Alberta at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jul 2022to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with traumatic SCI with onset ≥3 months prior,
- Between 18 - 65 yr old,
- ASIA Impairment Scale at discharge classified as A, B or C,
- Injury level between C5 and T10,
- Able to give informed, written consent.
Who cannot join
- Frequent uncontrolled autonomic dysreflexia,
- Uncontrolled high blood pressure,
- Cardiac or cardiovascular disease,
- Cancer,
- Active urinary tract infection,
- Active pressure sores,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta, Clinical Sciences Bldg
Edmonton, Alberta, T6G 2B7
Michelle Barnes, 7804055917, carre@ualberta.ca
Jaynie Yang, 7804922894, jaynie@ualberta.ca
About this study
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).
Read the detailed description
This proof-of-principle study will include a small number of participants with subacute or chronic (>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen.
Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects.
If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken
- Conditions
- Spinal Cord Injuries
- Being tested
- Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
- Keywords
- Hypoxia, Hyperoxia, Reflex, Sensation
- Medical subject headings
- Spinal Cord Injuries, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408Drug
Also called Compressed air from Praxair, DIN# 02014483
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxia followed by room air | Experimental | 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. Receives: Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 |
| Room air followed by hyperoxia | Placebo comparator | 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. Receives: Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Measured: Pre-intervention (exposure to high oxygen)
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Measured: Immediately after intervention (exposure to high oxygen)
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Measured: Pre-intervention (exposure to room air)
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Measured: Immediately after intervention (exposure to room air)
Secondary outcomes (4)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Measured: Pre-intervention (exposure to high oxygen)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Measured: Immediately after intervention (exposure to high oxygen)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Measured: Pre-intervention (exposure to room air)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Measured: Immediately after intervention (exposure to room air)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start11 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, double-blind, randomized crossover design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jaynie Yang, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467215
- Sponsor's protocol ID
- Pro00061817
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
- ClinicalTrials.gov ID
- NCT05467215
- Acronym / sponsor ID
- Pro00061817
- Conditions
- Spinal Cord Injuries
- Keywords
- Hypoxia, Hyperoxia, Reflex, Sensation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This proof-of-principle study will include a small number of participants with subacute or chronic (>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen.
Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects.
If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blind, randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia followed by room air | Experimental | Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408Group 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. |
| Room air followed by hyperoxia | Placebo comparator | Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408Group 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with traumatic SCI with onset ≥3 months prior,
- Between 18 - 65 yr old,
- ASIA Impairment Scale at discharge classified as A, B or C,
- Injury level between C5 and T10,
- Able to give informed, written consent.
Key exclusion criteria (12 listed)
- Frequent uncontrolled autonomic dysreflexia,
- Uncontrolled high blood pressure,
- Cardiac or cardiovascular disease,
- Cancer,
- Active urinary tract infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408Also: Compressed air from Praxair, DIN# 02014483Participants 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. | Drug | Hyperoxia followed by room air, Room air followed by hyperoxia |
Primary outcome
Skin Sensation
Time frame: Pre-intervention (exposure to high oxygen)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Skin Sensation
Time frame: Immediately after intervention (exposure to high oxygen)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Skin Sensation
Time frame: Pre-intervention (exposure to room air)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Skin Sensation
Time frame: Immediately after intervention (exposure to room air)
Quantification using von Frey Hairs at three locations above and below the level of injury.
4 secondary outcomes
Reflex Excitability
Time frame: Pre-intervention (exposure to high oxygen)
Reflex Excitability
Time frame: Immediately after intervention (exposure to high oxygen)
Reflex Excitability
Time frame: Pre-intervention (exposure to room air)
Reflex Excitability
Time frame: Immediately after intervention (exposure to room air)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaynie Yang principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 in people with Spinal Cord Injuries, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Barnes, PT (780-492-4858, carre@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Sensation (time frame: Pre-intervention (exposure to high oxygen)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.