RecruitingEarly Phase 1NCT05467215

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


Sponsor

University of Alberta

Enrollment

25 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria12

  • 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.

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Interventions

DRUGPure 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.


Locations(1)

University of Alberta, Clinical Sciences Bldg

Edmonton, Alberta, Canada

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NCT05467215


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