drugset / Trial / NCT07113158

Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

NCT07113158

Phase 3 Not yet recruiting 142 enrolled Assistance Publique - Hôpitaux de Paris
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

EvaluationDrugModalityDoseRoute
Subject Acid folic Unknown 5 mg
Subject Aspirin Small molecule 100 mg