drugset / Trial / NCT07113158
Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss
RandomizedParallel-groupTriple-blindTreatment
Summary
The annual incidence of sudden sensorineural hearing loss (SSNHL) is 5 to 20 per 100 000 persons. The pathophysiology of SSNHL and acute vestibulo-cochlear syndromes (VCS) is unknown in more than 70% of cases. Hypothesis : an inner ear microvascular disease represents the key element in the pathogenesis of SSNHL and acute VCS. Plasma serotonin has among other tissular effect a vasospastic on microcirculation such as the inner ear microvascularisation. Increased plasma homocysteine has a deleterious effect on vascular endothelium. Inner ear microvascularisation sensitized by an increased homocysteine level and the vascular wall would vasoconstrict under serotonin stimulation inducing ischemia of the vestibular and/or cochlear organs.
Timeline
- Start
- 2026-04-01
- Primary completion
- 2029-04-01
- Completion
- 2029-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acid folic | Unknown | 5 mg | — |
| Subject | Aspirin | Small molecule | 100 mg | — |