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

NCT05467215 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Pro00061817
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Keywords

Hypoxia; Hyperoxia; Reflex; Sensation

Outcome Measures

Primary Outcomes (4)

• Skin Sensation

  Quantification using von Frey Hairs at three locations above and below the level of injury.

  Pre-intervention (exposure to high oxygen)

• Skin Sensation

  Quantification using von Frey Hairs at three locations above and below the level of injury.

  Immediately after intervention (exposure to high oxygen)

• Skin Sensation

  Quantification using von Frey Hairs at three locations above and below the level of injury.

  Pre-intervention (exposure to room air)

• Skin Sensation

  Quantification using von Frey Hairs at three locations above and below the level of injury.

  Immediately after intervention (exposure to room air)

Secondary Outcomes (4)

• Reflex Excitability

  Pre-intervention (exposure to high oxygen)

• Reflex Excitability

  Immediately after intervention (exposure to high oxygen)

• Reflex Excitability

  Pre-intervention (exposure to room air)

• Reflex Excitability

  Immediately after intervention (exposure to room air)

Study Arms (2)

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.

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.

Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408

Interventions

Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 DRUG

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.

Also known as: Compressed air from Praxair, DIN# 02014483

Hyperoxia followed by room air; Room air followed by hyperoxia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Frequent uncontrolled autonomic dysreflexia,
• Uncontrolled high blood pressure,
• Cardiac or cardiovascular disease,
• Cancer,
• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta, Clinical Sciences Bldg

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Hypoxia; Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Jaynie Yang

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Barnes, PT

CONTACT

780-492-4858; carre@ualberta.ca

Jaynie Yang, PT, PhD

CONTACT

7804922894; jaynie@ualberta.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants with SCI will be masked. The experimenter collecting the sensory data and the experimenter analyzing the reflex data will be masked to the oxygen/air exposure, to avoid bias. The participant and the experimenter will be unmasked once all data collection has been completed for the participant.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, double-blind, randomized crossover design

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 20, 2022
• Study Start: July 11, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)