Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

Condition(s) studied

Investigational drug(s) / intervention(s)

Aspirin + Acid folic: Aspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment

Placebo Aspirin + Placebo Acid folic: The Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment

Study 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.

Eligibility

Primary outcome measure(s)

• 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 — At Day 15
  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.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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