Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Aspirin + Acid folic
  • Placebo Aspirin + Placebo Acid folic

Treatment groups

142 Participants
are divided into 2 treatment groups