Not Yet RecruitingPhase 3

Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

France142 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral SSNHL defined as a sudden hearing loss of 30dB or greater at least three contiguous audiometric frequencies (between 125hz and 8000Hz) occurring within a 72 hr period and for less than 15 days. * Individuals affiliated to a social security regimen * Individuals able to participate and to follow up during the study period Exclusion Criteria: * Contra-indications to Aspirin, contra-indications to oral corticosteroid therapy, contra-indications to dexamethasone, allergy to vitamin B9 * Evident cause of acute SSNHL including tumor of the ponto-cerebellous angle, infectious labyrinthitis, mechanical and acoustic trauma, malformation of the inner ear, neurological disorder. * Patient already including in another clinical trial * Person under legal protection (under guardianship or curatorship) * Patients taking serotonin reuptake inhibitors * Patients already taking aspirin or other anticoagulant or antiplatelet agent

What they're measuring

Mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 as defined by the AAO-HNS

Timeframe: At Day 15

Trial details

NCT IDNCT07113158

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01

Contact for this trial

Charlotte HAUTEFORT, Dr

0149958062 charlotte.hautefort@aphp.fr