Using mild intermittent hypoxia to prevent autonomic dysfunction in spinal cord injury patients
Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries
This study is testing if mild intermittent hypoxia can help people with spinal cord injuries improve their blood pressure control and overall health by preventing autonomic dysfunction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05351827 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of mild intermittent hypoxia (MIH) as a preventive measure for autonomic dysfunction in individuals with spinal cord injuries (SCI). Patients with SCI above the 6th thoracic vertebrae often experience severe autonomic dysfunction, leading to conditions like autonomic dysreflexia and orthostatic hypotension. The study aims to determine if exposure to MIH can restore blood pressure control and improve overall health outcomes for these patients. Participants will be monitored for changes in autonomic function and related health metrics during the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with motor incomplete spinal cord injuries at or above the 12th thoracic vertebrae who exhibit signs of autonomic dysfunction.
Not a fit: Patients with complete spinal cord injuries or those with other significant health issues such as insulin-dependent diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood pressure control and reduce cardiovascular risks for patients with spinal cord injuries.
How similar studies have performed: While the use of mild intermittent hypoxia is a novel approach in this context, similar interventions have shown promise in improving health outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-60 2. Motor incomplete spinal cord injury at or above the 12th thoracic vertebrae 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. Chronic injuries (\> 1 year post injury) Exclusion Criteria: 1. Pregnant 2. Smoker 3. Drug addiction 4. \<18 or \>60 years of age 5. Complete spinal cord injury 6. Spinal cord injury below the 6th thoracic vertebrae 7. Insulin dependent diabetes 8. Shift workers (ie disrupted circadian rhythm) 9. Active skin breakdown or pressure sores
Where this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Gino Panza, PhD — John D. Dingell VA Medical Center, Detroit, MI
- Study coordinator: Gino Panza, PhD
- Email: Gino.Panza@va.gov
- Phone: (313) 576-1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.