Low-oxygen breathing to improve 24-hour blood pressure stability after cervical spinal cord injury
Low Oxygen Therapy as a Cardiac Treatment for Improving 24-hour Blood Pressure Stability in Spinal Cord Injury
This trial will try whether brief sessions of breathing lower-oxygen air can improve 24-hour blood pressure stability in adults with chronic cervical spinal cord injury.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Kelowna, British Columbia and 1 other locations) |
| Trial ID | NCT06691165 on ClinicalTrials.gov |
What this trial studies
Researchers will deliver a 4-day low oxygen therapy (LOT) intervention made of repeated, brief exposures to reduced inspired oxygen via a facemask for people with chronic cervical spinal cord injury. They will measure 24-hour ambulatory blood pressure and perform tests of cardiac, vascular, and autonomic function before and after the intervention. Eligible participants are adults aged 19–65 with chronic cervical (at or above T1) injuries who can breathe without ventilator support and meet safety criteria. The trial aims to see if LOT can reduce blood pressure swings that contribute to increased cardiovascular risk in this population.
Who should consider this trial
Good fit: Adults aged 19–65 with a chronic cervical spinal cord injury (at or above T1) of at least one year who can tolerate a facemask and do not require ventilator support.
Not a fit: People with high-cervical injuries requiring ventilator assistance, uncontrolled cardiovascular or pulmonary disease, seizure disorders, severe recurrent autonomic dysreflexia, or other excluded conditions (including pregnancy) are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, LOT could reduce dangerous blood pressure swings and lower long-term cardiovascular risk in people with cervical spinal cord injury.
How similar studies have performed: Previous work shows LOT can raise blood pressure in able-bodied people and can improve respiratory and motor function in some people with SCI, but its cardiovascular effects in people with SCI have not been tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are between the ages of 19-65 * Living with a chronic cervical (at or above T1) spinal cord injury of at least one year * Are fluent in english Exclusion Criteria: * High-cervical injuries requiring ventilator assistance to breathe will be excluded on account of the necessity of the facemask for the delivery of hypoxia * Unhealed fracture, contracture, or pressure sore that might interfere with participants' ability to complete the protocol * Additional concurrent neurological conditions (e.g., multiple sclerosis, Parkinson disease, stroke or brain injury) * Uncontrolled cardiovascular or pulmonary disease * Severe neuropathic pain * Severe recurrent autonomic dysreflexia * History of seizure disorders * Known pregnancy
Where this trial is running
Kelowna, British Columbia and 1 other locations
- UBC Okanagan — Kelowna, British Columbia, Canada (Recruiting)
- International Collaboration on Repair Discoveries (ICORD) — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Scott F Thrall, M.Sc.
- Email: sthrall@student.ubc.ca
- Phone: +1 250-807-8083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.