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Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

NCT07113158 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

  • Sudden Sensorineural Hearing Loss

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-04-01
Completion
2029-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113158 on ClinicalTrials.gov