Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT05351827

Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries

Led by VA Office of Research and Development · Updated on 2025-09-22

24

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

J

John D. Dingell VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-60 years
  • Motor incomplete spinal cord injury at or above the 12th thoracic vertebrae
  • Signs or symptoms of autonomic dysfunction based on specific questionnaire scores
  • Chronic spinal cord injuries more than 1 year post injury
Not Eligible

You will not qualify if you...

  • Pregnant
  • Smoker
  • Drug addiction
  • Younger than 18 or older than 60 years
  • Complete spinal cord injury
  • Spinal cord injury below the 6th thoracic vertebrae
  • Insulin dependent diabetes
  • Shift workers with disrupted circadian rhythm
  • Active skin breakdown or pressure sores

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States, 48201-1916

Actively Recruiting

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Research Team

G

Gino Panza, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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