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.
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
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)
Parallel
Aspirin + Acid folic
DrugAspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment
Placebo Aspirin + Placebo Acid folic
DrugThe Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment
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
Complete recovery with return to less than 10 dB HL of the unaffected ear, no recovery : anything below 10 dB. Partial recovery is between the two extremes.
Maximal speech intelligibility (word recognition) score at D15, M3 and M6
Mean of pure tones defined as the mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at M3 and M6 as defined by the AAO-HNS
Complete recovery with return to less than 10 dB HL of the unaffected ear, no recovery : anything below 10 dB. Partial recovery is between the two extremes.
Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6
Vestibular function assessed at D15, M3 and M6 with: • presence or absence of a spontaneous and positional nystagmus • mean gains of the vestibulo-ocular reflex measured by the vHIT
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