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NCT05351827 · ClinicalTrials.gov registry record · NA
Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries
A NA study of Spinal Cord Injuries and Autonomic Dysreflexia, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05351827 is a NA study of Spinal Cord Injuries and Autonomic Dysreflexia that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 24 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05351827, a NA study of Spinal Cord Injuries and Autonomic Dysreflexia, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Mild Intermittent Hypoxia
- OTHER Sham
Study Locations (1)
Michigan
- John D. Dingell VA Medical Center, Detroit, MI - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2026-10-29 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05351827
The ClinicalTrials.gov registry entry for NCT05351827 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (61% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Mild Intermittent Hypoxia is the first listed.
NCT05351827 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT05351827 about?
NCT05351827 is a clinical study titled "Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries". 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...
What is the current status of trial NCT05351827?
This trial is currently recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2022-10-01. Estimated completion is 2026-10-29.
What conditions does trial NCT05351827 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Autonomic Dysreflexia.
What interventions are being tested in trial NCT05351827?
The interventions under investigation include: Mild Intermittent Hypoxia (OTHER), Sham (OTHER).
Who is sponsoring clinical trial NCT05351827?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05351827 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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