Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07113158
PHASE3

Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2026-04-01

Completion Date

2029-11-01

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DRUG

Aspirin + Acid folic

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

DRUG

Placebo Aspirin + Placebo Acid folic

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

Locations (1)

Lariboisière Hospital

Paris, Île-de-France Region, France