NCT05351827 Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries
| NCT ID | NCT05351827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2022-10-01 with a primary completion date of 2026-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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
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
Contact & Investigator
Gino Panza, PhD
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI
Frequently Asked Questions
Who can join the NCT05351827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05351827 currently recruiting?
Yes, NCT05351827 is actively recruiting participants. Contact the research team at Gino.Panza@va.gov for enrollment information.
Where is the NCT05351827 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05351827 clinical trial?
NCT05351827 is sponsored by VA Office of Research and Development. The principal investigator is Gino Panza, PhD at John D. Dingell VA Medical Center, Detroit, MI. The trial plans to enroll 24 participants.