What side effects are associated with this type of intervention?

Common treatments for Autonomic Dysreflexia (AD) include pharmacologic interventions such as antihypertensive medications, which can cause side effects like hypotension, dizziness, and bradycardia. Non-pharmacologic treatments, such as physical therapy and behavioral modifications, generally have fewer side effects but may not be as immediately effective. Treatments similar to Mild Intermittent Hypoxia (MIH), which aim to restore homeostatic blood pressure control and address autonomic dysfunction, are still under investigation. Potential side effects of MIH could include transient hypoxia-related symptoms such as headache, dizziness, and shortness of breath, but more research is needed to fully understand its safety profile.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Autonomic Dysreflexia that directly align with the mechanisms of Mild Intermittent Hypoxia (MIH), which focuses on restoring homeostatic blood pressure control and addressing autonomic control and sleep-disordered breathing (SDB) co-morbidities. However, treatments for Autonomic Dysreflexia generally include medications such as antihypertensives to manage blood pressure spikes. Non-pharmacological approaches, like MIH, are being explored for their potential benefits in autonomic regulation and cardiovascular health in patients with spinal cord injuries.

What other types of research exist?

Promising alternatives to MIH for treating Autonomic Dysreflexia in 2024 include Continuous Positive Airway Pressure (CPAP) therapy, which has been shown to improve pulmonary hemodynamics and reduce cardiovascular risks associated with SDB. Additionally, pharmacological treatments such as eplerenone and perindopril, which have demonstrated benefits in managing cardiovascular complications, may also be considered.

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Mild Intermittent Hypoxia for Spinal Cord Injury (MIH and AD Trial)

N/A

Recruiting

Led By Gino Panza, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-60

Motor incomplete spinal cord injury at or above the 6th thoracic vertebrae

Must not have

Complete spinal cord injury

Spinal cord injury below the 6th thoracic vertebrae

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes, pre-intervention, 1 day after intervention, 2 weeks after intervention

Summary

This trial is testing whether low oxygen exposure can help people with spinal cord injuries who have trouble controlling their blood pressure and breathing during sleep. The goal is to see if this treatment can improve their health and make daily activities easier for them.

Who is the study for?

This trial is for individuals aged 18-60 with motor incomplete spinal cord injuries above the 6th thoracic vertebrae and signs of autonomic dysfunction. It's not for those with complete SCI, injuries below T6, disrupted sleep patterns, pregnancy, smokers, drug addiction, age outside the specified range or active skin sores.

What is being tested?

The study tests mild intermittent hypoxia (MIH) as a preventive treatment for autonomic dysfunction in people with spinal cord injury. Participants will be exposed to MIH to see if it helps regulate blood pressure control and reduce complications related to sleep disordered breathing.

What are the potential side effects?

Potential side effects may include discomfort from lack of oxygen (hypoxia), changes in heart rate or blood pressure during exposure sessions. However, specific side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have a partial spinal cord injury above my chest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a complete spinal cord injury.

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My spinal cord injury is below the middle of my back.

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I am either younger than 18 or older than 60.

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I have open wounds or pressure sores on my skin.

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I use insulin to manage my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention, 1 day after intervention, 2 weeks after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention, 1 day after intervention, 2 weeks after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention, 1 day after intervention, 2 weeks after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Autonomic Dysreflexia

Secondary study objectives

24-hour blood pressure variability

Orthostatic Hypotension

Spinal Cord Independence Measure (SCIM III)

Other study objectives

Microvascular function

Mitochondrial Capacity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mild Intermittent HypoxiaExperimental Treatment1 Intervention

This arm of the protocol will receive mild intermittent hypoxia (8% Oxygen) with end-tidal carbon dioxide maintained 1-3 millimeters of mercury above baseline, while in the laboratory. If diagnosed with sleep apnea, participants will be treated with continuous positive airway pressure for the duration of the intervention.

Group II: ShamPlacebo Group1 Intervention

This arm of the protocol will receive sham air (21 % Oxygen) while in the laboratory. No additional gases will be employed. If diagnosed with sleep apnea, participants will be treated with continuous positive airway pressure for the duration of the intervention.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Autonomic Dysreflexia (AD) include pharmacologic agents like antihypertensives and non-pharmacologic interventions such as Mild Intermittent Hypoxia (MIH). Antihypertensives work by lowering blood pressure, thus preventing the dangerous spikes associated with AD. MIH, on the other hand, promotes the restoration of homeostatic blood pressure control and targets mechanisms associated with autonomic control and sleep-disordered breathing (SDB) co-morbidities. This is particularly important for AD patients as it helps stabilize blood pressure and improve autonomic function, thereby reducing the frequency and severity of AD episodes and enhancing overall cardiovascular health.

Ventilatory, hemodynamic, sympathetic nervous system, and vascular reactivity changes after recurrent nocturnal sustained hypoxia in humans.Nitric Oxide Deficit Is Part of the Maladaptive Paracrine-Autocrine Response of the Carotid Body to Intermittent Hypoxia in Sleep Apnea.Intermittent hypoxia: cause of or therapy for systemic hypertension?