Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Co… (NCT05351827) | Clinical Trial Compass
RecruitingNot Applicable
Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries
United States24 participantsStarted 2022-10-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Autonomic Dysreflexia
Timeframe: 6 minutes, Pre-Intervention, 1 Day after intervention, 2 weeks after intervention