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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Pregnant

Smoker

Drug addiction

<18 or >60 years of age

Trial design

Treatments tested in this trial

  • Mild Intermittent Hypoxia
  • Sham

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

John D. Dingell VA Medical Center

Collaborator