RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-01
Study Completion:2026-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05351827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-60
  2. 2. Motor incomplete spinal cord injury at or above the 12th thoracic vertebrae
  3. 3. 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)
  4. 4. Chronic injuries (\> 1 year post injury)
  1. 1. Pregnant
  2. 2. Smoker
  3. 3. Drug addiction
  4. 4. \<18 or \>60 years of age
  5. 5. Complete spinal cord injury
  6. 6. Spinal cord injury below the 6th thoracic vertebrae
  7. 7. Insulin dependent diabetes
  8. 8. Shift workers (ie disrupted circadian rhythm)
  9. 9. Active skin breakdown or pressure sores

Contacts and Locations

Study Contact

Gino Panza, PhD
CONTACT
(313) 576-1000
Gino.Panza@va.gov

Principal Investigator

Gino Panza, PhD
PRINCIPAL_INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI

Study Locations (Sites)

John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Gino Panza, PhD, PRINCIPAL_INVESTIGATOR, John D. Dingell VA Medical Center, Detroit, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2026-10-29

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2026-10-29

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Autonomic Dysreflexia