Spinal Cord InjuryPhase 1/2NCT06691165
Improving 24-hour Blood Pressure Stability in Spinal Cord Injury With Low Oxygen Therapy
A Phase 1/2 study testing Low oxygen therapy (LOT) in people with Spinal Cord Injury, run by Glen Foster at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Low oxygen therapy (LOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Oct 2025to Dec 2026
- Phase
- Phase 1/2
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
UBC Okanagan
Kelowna, British Columbia, V1V 1V7
Scott Thrall, MSc, 2508078083, sthrall@student.ubc.ca
Glen Foster, PhD, 250-807-8224, glen.foster@ubc.ca
- Recruiting
International Collaboration on Repair Discoveries (ICORD)
Vancouver, British Columbia, V5Z 1N1
Scott Thrall, MSc, 2508078083, sthrall@student.ubc.ca
Glen Foster, PhD, 250-807-8224, glen.foster@ubc.ca
About this study
Official title: Low Oxygen Therapy as a Cardiac Treatment for Improving 24-hour Blood Pressure Stability in Spinal Cord Injury
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.
Read the detailed description
Spinal cord injury (SCI) interrupts signals travelling down from the brain to the rest of the body below the level of the injury. The loss of nerve connections involved in cardiovascular control results in blood pressure instability. This can lead to sudden drops in blood pressure, such as when shifting upright or during transfers, or sudden increases during autonomic dysreflexia. These swings in blood pressure are linked to a nearly 4-fold increase in the risk of cardiovascular disease in people with SCI.
Repeated, brief exposure to breathing lower levels of oxygen, termed low oxygen therapy, has been shown to stimulate adaptation in the nervous system. This neuroplasticity increases the activity of cardiovascular control circuits, and has been shown to increase blood pressure in able-bodied individuals. Similar effects on respiratory and motor function in people with SCI, but the effects on the cardiovascular system have not been studied in this population.
This study will test the effects of a 4-day low oxygen therapy intervention on 24-hour blood pressure stability in people with chronic cervical SCI. By assessing mechanisms of cardiac, vascular, and autonomic function, this study aims to improve current understanding of the therapeutic potential of low oxygen therapy to mitigate cardiovascular disease risk in SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- Low oxygen therapy (LOT)
- Keywords
- Low oxygen therapy, Intermittent hypoxia, Blood pressure, Spinal cord injury, Cardiac function, Sympathetic nervous system
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low oxygen therapy (LOT)Drug
Also called Intermittent hypoxia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Low oxygen therapy (LOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour blood pressure
Mean arterial blood pressure (mmHg), averaged across 24 hours
Measured: 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
Mean arterial blood pressure (mmHg), standard deviation across 24 hours
Measured: Change from baseline of the standard deviation of 24-hour mean arterial blood pressure at 1-day post-intervention
Change in left-ventricular contractility
Indices of load-independent pressure generation during systole: Estimated end-systolic elastance (mmHg/ml); end-systolic pressure-volume relationship slopes (mmHg/ml)
Measured: 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
Indices of baroreflex sensitivity: Relationship of systolic blood pressure against subsequent R-R interval duration during Valsalva Maneuver phases II and IV (ms/mmHg); spectral power of low-frequency resting blood pressure variability
Measured: 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
Venous plasma concentrations of norepinephrine and epinephrine (mmol/L)
Measured: 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
Middle and posterior cerebral artery blood flow velocity (cm/s)
Measured: 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
Change in renal filtration function
Humoral renal biomarkers (e.g., serum creatinine)
Measured: Change from baseline in renal biomarkers and blood flow at rest immediately after first intervention session, and at 1-day and 4-days post-intervention
Change in flow-mediated dilation
Brachial artery flow-mediated dilation following 5-minute forearm blood flow occlusion (mm)
Measured: Change from baseline in flow-mediated dilation immediately after first intervention session, and at 1-day and 4-days post-intervention
Change in tonic peripheral chemoreflex activity
Magnitude of hyperoxic ventilatory depression (L/min)
Measured: Change from baseline in the magnitude of ventilatory depression in hyperoxia immediately after first intervention session, and at 1-day and 4-days post-intervention
Change in renal vascular function
Renal artery blood flow velocity (cm/s)
Measured: Change in renal blood flow velocity from baseline during the first and final hypoxia cycles on the first session of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start23 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glen Foster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Glen Foster, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691165
- Sponsor's protocol ID
- H24-02648
- Other IDs
- F23-01237
- Status last verified
- Nov 2025
- First submitted
- 23 Oct 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32744340Claydon 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.
PubMed 16304564Vose 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.
PubMed 34637802Perim 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.
PubMed 37451584Welch 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.
PubMed 38468543
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Oxygen Therapy as a Cardiac Treatment for Improving 24-hour Blood Pressure Stability in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06691165
- Acronym / sponsor ID
- H24-02648
- Conditions
- Spinal Cord Injury
- Keywords
- Low oxygen therapy, Intermittent hypoxia, Blood pressure, Spinal cord injury, Cardiac function, Sympathetic nervous system
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Glen FosterUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Nov 2024 (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 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.
Detailed description
Spinal cord injury (SCI) interrupts signals travelling down from the brain to the rest of the body below the level of the injury. The loss of nerve connections involved in cardiovascular control results in blood pressure instability. This can lead to sudden drops in blood pressure, such as when shifting upright or during transfers, or sudden increases during autonomic dysreflexia. These swings in blood pressure are linked to a nearly 4-fold increase in the risk of cardiovascular disease in people with SCI.
Repeated, brief exposure to breathing lower levels of oxygen, termed low oxygen therapy, has been shown to stimulate adaptation in the nervous system. This neuroplasticity increases the activity of cardiovascular control circuits, and has been shown to increase blood pressure in able-bodied individuals. Similar effects on respiratory and motor function in people with SCI, but the effects on the cardiovascular system have not been studied in this population.
This study will test the effects of a 4-day low oxygen therapy intervention on 24-hour blood pressure stability in people with chronic cervical SCI. By assessing mechanisms of cardiac, vascular, and autonomic function, this study aims to improve current understanding of the therapeutic potential of low oxygen therapy to mitigate cardiovascular disease risk in SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Room air control; lot oxygen therapy; recovery/washout | Experimental | Drug: Low oxygen therapy (LOT)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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Low oxygen therapy (LOT)Also: Intermittent hypoxiaParticipants 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. | Drug | Room air control; lot oxygen therapy; recovery/washout |
Primary outcome
Change in 24-hour blood pressure
Time frame: Change from baseline of 24-hour mean arterial blood pressure at 1-day post-intervention
Mean arterial blood pressure (mmHg), averaged across 24 hours
9 secondary outcomes
Change in 24-hour blood pressure stability
Time frame: Change from baseline of the standard deviation of 24-hour mean arterial blood pressure at 1-day post-intervention
Change in left-ventricular contractility
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Change in renal filtration function
Time frame: Change from baseline in renal biomarkers and blood flow at rest immediately after first intervention session, and at 1-day and 4-days post-intervention
Change in flow-mediated dilation
Time frame: Change from baseline in flow-mediated dilation immediately after first intervention session, and at 1-day and 4-days post-intervention
Change in tonic peripheral chemoreflex activity
Time frame: Change from baseline in the magnitude of ventilatory depression in hyperoxia immediately after first intervention session, and at 1-day and 4-days post-intervention
Change in renal vascular function
Time frame: Change in renal blood flow velocity from baseline during the first and final hypoxia cycles on the first session of the intervention
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 18 Nov 2025.
- Background: PubMed 32744340Vermeulen 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.
- Background: PubMed 16304564Claydon 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.
- Background: PubMed 34637802Vose 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.
- Background: PubMed 37451584Perim 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.
- Background: PubMed 38468543Welch 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.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low oxygen therapy (LOT) in people with Spinal Cord Injury, run by Glen Foster at 2 sites 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 3 inclusion and 8 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Scott F Thrall, M.Sc. (+1 250-807-8083, sthrall@student.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour blood pressure (time frame: Change from baseline of 24-hour mean arterial blood pressure at 1-day post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06691165, which also lists 5 linked publications.
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 18 Nov 2025.