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

Glen Foster

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Spinal Cord Injury

Treatments: Other: Low oxygen therapy (LOT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06691165

H24-02648

F23-01237 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Room air control; lot oxygen therapy; recovery/washout

Experimental group

Description:

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.

Treatment:

Other: Low oxygen therapy (LOT)