Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

NCT07113158 | Not Yet Recruiting Phase 3

• 2 other identifiers: APHP2308362024-513710-35
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SSNHL; sudden sensorineural hearing loss; sudden hearing loss; aspirin; acid folic

Outcome Measures

Primary Outcomes (1)

• 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.

  At Day 15

Secondary Outcomes (4)

• Maximal speech intelligibility (word recognition) score at D15, M3 and M6

  At day 15, 3 month, 6 month

• 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

  At month 3, month 6

• Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6

  At day 15, month 3, month 6

• 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

  At day 15, month 3, month 6

Study Arms (2)

Investigational medicinal products

EXPERIMENTAL

Aspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment (oral corticosteroid therapy 1 mg/kg +/- 3 trans-tympanic injections of dexamethasone) * Corticosteroid therapy 1mg/kg/day for 7 days * 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months

Drug: Aspirin + Acid folic

Comparator treatment

PLACEBO COMPARATOR

The Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment (oral corticosteroid therapy 1mg/kg +/- 3 trans-tympanic injections of dexamethasone) * Corticosteroid therapy 1mg/kg/day for 7 days * 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months

Drug: Placebo Aspirin + Placebo Acid folic

Interventions

Aspirin + Acid folic DRUG

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

Investigational medicinal products

Placebo Aspirin + Placebo Acid folic DRUG

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

Comparator treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Lariboisière Hospital

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Aspirin; Folic Acid

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Charlotte HAUTEFORT, Dr

CONTACT

0149958062; charlotte.hautefort@aphp.fr

Ludovic DROUET

CONTACT

0149956414; ludovic.drouet-ext@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a national phase III, clinical study, multicenter, comparative, randomized on 2 parallel groups, with one group control, of superiority, double blind for the patients, the investigators and the study site staff. Participants distributed between groups at a ratio of (1: 1).

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: August 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

FR (1)