Improving 24-hour Blood Pressure Stability in Spinal Cord Injury With Low Oxygen Therapy

NCT06691165 | Recruiting Phase 1

• 2 other identifiers: H24-02648F23-01237
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This study examines the effects of low oxygen therapy (LOT) on the stability of 24-hour blood pressure in persons with chronic cervical spinal cord injury. This study will examine if brief episodes of breathing lower oxygen, termed low oxygen therapy (LOT), which has been shown to enhance autonomic nervous system activity, can improve blood pressure stability in individuals with spinal cord injury. The research team will assess 24-hour blood pressure, as well as cardiac, vascular, and autonomic function before and after a 4-day LOT treatment intervention. This study will advance current understanding of treatments to mitigate cardiovascular disease risk in people with spinal cord injuries.

Conditions

Spinal Cord Injury

Keywords

Low oxygen therapy; Intermittent hypoxia; Blood pressure; Spinal cord injury; Cardiac function; Sympathetic nervous system

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour blood pressure

  Mean arterial blood pressure (mmHg), averaged across 24 hours

  Change from baseline of 24-hour mean arterial blood pressure at 1-day post-intervention

Secondary Outcomes (9)

• Change in 24-hour blood pressure stability

  Change from baseline of the standard deviation of 24-hour mean arterial blood pressure at 1-day post-intervention

• Change in left-ventricular contractility

  Change from baseline of left ventricular contractility indices immediately after the first intervention session, and at 1-day and 4-days post-intervention

• Change in baroreflex gain

  Change from baseline of baroreflex gain indices immediately after first intervention session, and at 1-day and 4-days post-intervention

• Change in circulating catecholamines

  Change from baseline of circulating catecholamines immediately after first intervention session, and at 1-day and 4-days post-intervention

• Change in cerebral neurovascular coupling and autoregulation

  Change from baseline of the responses of cerebral blood flow indices during a visual stimulus and head-up tilt immediately after first intervention session, and at 1-day and 4-days post-intervention

Study Arms (1)

Room air control; lot oxygen therapy; recovery/washout

EXPERIMENTAL

Participants with chronic cervical spinal cord injury will undergo a 4-day low oxygen therapy intervention. Measurements will first be taken at least three days before the beginning of the intervention to establish baseline characteristics, immediately before and after the first day of the intervention to assess the acute response to the intervention, and on the first and fourth days after the end of the intervention to assess persistent effects and washout.

Drug: Low oxygen therapy (LOT)

Interventions

Low oxygen therapy (LOT) DRUG

Participants will breathe variable concentrations of inspired oxygen, carbon dioxide, and nitrogen. The concentrations will be adjusted on a breath-by-breath basis to maintain end-tidal targets. Each daily session of the intervention will consist of forty 1-minute intervals. Each 1-minute interval will consist of 40 seconds of hypercapnic hypoxia, increasing the partial pressure of end-tidal carbon dioxide by +4 mmHg and decreasing the partial pressure of end-tidal oxygen to 45 mmHg, followed by 20 seconds in simulated room air to return to baseline carbon dioxide and oxygen levels.

Also known as: Intermittent hypoxia

Room air control; lot oxygen therapy; recovery/washout

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glen Foster: lead

Study Sites (2)

UBC Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

RECRUITING

International Collaboration on Repair Discoveries (ICORD)

Vancouver, British Columbia, V5Z 1N1, Canada

RECRUITING

Related Publications (5)

• Vermeulen TD, Benbaruj J, Brown CV, Shafer BM, Floras JS, Foster GE. Peripheral chemoreflex contribution to ventilatory long-term facilitation induced by acute intermittent hypercapnic hypoxia in males and females. J Physiol. 2020 Oct;598(20):4713-4730. doi: 10.1113/JP280458. Epub 2020 Aug 19.

  PMID: 32744340 BACKGROUND

• Claydon VE, Steeves JD, Krassioukov A. Orthostatic hypotension following spinal cord injury: understanding clinical pathophysiology. Spinal Cord. 2006 Jun;44(6):341-51. doi: 10.1038/sj.sc.3101855. Epub 2005 Nov 22.

  PMID: 16304564 BACKGROUND

• Vose AK, Welch JF, Nair J, Dale EA, Fox EJ, Muir GD, Trumbower RD, Mitchell GS. Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. Exp Neurol. 2022 Jan;347:113891. doi: 10.1016/j.expneurol.2021.113891. Epub 2021 Oct 9.

  PMID: 34637802 BACKGROUND

• Perim RR, Vinit S, Mitchell GS. Cervical spinal hemisection effects on spinal tissue oxygenation and long-term facilitation of phrenic, renal and splanchnic sympathetic nerve activity. Exp Neurol. 2023 Oct;368:114478. doi: 10.1016/j.expneurol.2023.114478. Epub 2023 Jul 13.

  PMID: 37451584 BACKGROUND

• Welch JF, Vose AK, Cavka K, Brunetti G, DeMark LA, Snyder H, Wauneka CN, Tonuzi G, Nair J, Mitchell GS, Fox EJ. Cardiorespiratory Responses to Acute Intermittent Hypoxia in Humans With Chronic Spinal Cord Injury. J Neurotrauma. 2024 Sep;41(17-18):2114-2124. doi: 10.1089/neu.2023.0353. Epub 2024 Apr 18.

  PMID: 38468543 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Scott F Thrall, M.Sc.

CONTACT

+1 250-807-8083; sthrall@student.ubc.ca

Glen E Foster, Ph.D.

CONTACT

+1 250-807-8224; glen.foster@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 15, 2024
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)