Clinical Trial

Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

Study acronym: SERORL
Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-04.
Trial Details
NCT Number NCT07113158
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Sudden Sensorineural Hearing Loss
Enrollment 142 participants
Start Date 2026-04-01
Primary Completion 2029-04-01 (estimated)
Study Completion 2029-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-14