Status:
RECRUITING
Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
John D. Dingell VA Medical Center
Conditions:
Spinal Cord Injuries
Autonomic Dysreflexia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 (...
Detailed Description
Individuals with a spinal cord injury (SCI) above the 6th thoracic vertebrae experience severe autonomic dysfunction. These individuals lose the ability to control blood pressure (BP) during a noxious...
Eligibility Criteria
Inclusion
- Age 18-60
- Motor incomplete spinal cord injury at or above the 12th thoracic vertebrae
- Signs or symptoms of autonomic dysfunction (this will be determined by the ADFSCI and ISAFSCI questions. The ADFSCI requires a score of 1 on questions 16 and 22, and the ISAFSCI requires a score of 1 on any parameter)
- Chronic injuries (\> 1 year post injury)
Exclusion
- Pregnant
- Smoker
- Drug addiction
- \<18 or \>60 years of age
- Complete spinal cord injury
- Spinal cord injury below the 6th thoracic vertebrae
- Insulin dependent diabetes
- Shift workers (ie disrupted circadian rhythm)
- Active skin breakdown or pressure sores
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05351827
Start Date
October 1 2022
End Date
October 29 2026
Last Update
September 22 2025
Active Locations (1)
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1
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201-1916