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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: Recruiting NA study of Spinal Cord Injuries and Autonomic Dysreflexia, sponsored by VA Office of Research and Development.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Change in systolic blood pressure during thigh occlusion test.

Interventions

  • OTHER Mild Intermittent Hypoxia
  • OTHER Sham

Study Locations (1)

Michigan

  • John D. Dingell VA Medical Center, Detroit, MI - Detroit

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-10-01
Est. Completion 2026-10-29
Phase NA
VA Office of Research and Development

1,668 total trials

What NCT05351827 shows while recruiting

NCT05351827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (61% lower).

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 a single indexed study location in 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.

Similar trials for Spinal Cord Injuries

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05351827's enrollment target sits among peer trials

24 114th of 202 higher than 82 of 202 other Spinal Cord Injuries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05351827, the US trial registry maintained by the National Library of Medicine. NCT05351827 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.