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NCT05351827: MIH and AD

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

Recruiting now NA Last updated 22 September 2025
What this trial tests

NA trial testing Mild Intermittent Hypoxia in Spinal Cord Injuries in 24 participants. Currently enrolling.

Timeline
1 October 2022
Primary endpoint
29 October 2026
29 October 2026

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment24
Start date1 October 2022
Primary completion29 October 2026
Estimated completion29 October 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 60, any sex, with Spinal Cord Injuries or Autonomic Dysreflexia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mild intermittent hypoxia may improve autonomic dysfunction in persons living with spinal cord injury: a preliminary snapshot.
    Soltesz AE, Zhao F, Wecht JM, Mateika JH, et al · · 2025 · PMID 40766908 · DOI 10.3389/fnins.2025.1600772

Verify or expand the search:

Other trials of Mild Intermittent Hypoxia

Trials testing the same drug.

Other recruiting trials for Spinal Cord Injuries

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05351827.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing