Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Sudden Sensorineural Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT07113158
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 142
- Starts
- 2026-04-01
- Expected to finish
- 2029-11-01
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lariboisière Hospital — Paris, Île-de-France Region, France
Full record on ClinicalTrials.gov
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