Mild Intermittent Hypoxia for Autonomic Dysreflexia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
John D Dingell VAMC, Detroit, MI
Autonomic Dysreflexia+5 More
Mild Intermittent Hypoxia - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The prevalence of autonomic dysfunction and sleep disordered breathing (SDB) is increased in individuals with spinal cord injury (SCI). The loss of autonomic control results in autonomic dysreflexia (AD) and orthostatic hypotension (OH) which explains the increase in cardiovascular related mortality in these Veterans. There is no effective prophylaxis for autonomic dysfunction. The lack of prophylactic treatment for autonomic dysfunction, and no best clinical practices for SDB in SCI, are significant health concerns for Veterans with SCI. Therefore, the investigators will investigate the effectiveness of mild intermittent hypoxia (MIH) as a prophylactic for autonomic dysfunction in patients with SCI. The investigators propose that MIH targets several mechanisms associated with autonomic control and the co-morbidities associated with SDB. Specifically, exposure to MIH will promote restoration of homeostatic BP control, which would be beneficial to participation in daily activities and independence in those with SCI.

Eligible Conditions

  • Autonomic Dysreflexia
  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 15 minutes, Pre-Intervention, 1 Day after intervention, 2 weeks after intervention

Week 2
Orthostatic Hypotension
Week 2
24-hour blood pressure variability
Week 2
Autonomic Dysreflexia
Microvascular function
Mitochondrial Capacity
Week 2
Cardiac Function
Spinal Cord Independence Measure (SCIM III)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Mild Intermittent Hypoxia
1 of 2
Sham
1 of 2
Experimental Treatment
Non-Treatment Group

24 Total Participants · 2 Treatment Groups

Primary Treatment: Mild Intermittent Hypoxia · Has Placebo Group · N/A

Mild Intermittent Hypoxia
Other
Experimental Group · 1 Intervention: Mild Intermittent Hypoxia · Intervention Types: Other
Sham
Other
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 minutes, pre-intervention, 1 day after intervention, 2 weeks after intervention
Closest Location: John D Dingell VAMC · Detroit, MI
Photo of Detroit 1Photo of Detroit 2Photo of Detroit 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Autonomic Dysreflexia
0 CompletedClinical Trials

Who is running the clinical trial?

John D. Dingell VA Medical CenterFED
6 Previous Clinical Trials
482 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,457 Previous Clinical Trials
2,747,655 Total Patients Enrolled
Gino Panza, PhDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a motor incomplete spinal cord injury at or above the 6th thoracic vertebrae.
You have a chronic injury.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.