Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss

NCT ID: NCT07113158

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2029-11-01

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.

Detailed Description

Sudden sensorineural hearing loss (SSNHL) is defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring over 72 hr 9,10. SSNHL is a relatively common disorder in otologic and audiologic practices (1.5-1.7 per 100 new patients presenting in ENT practice. Most patients with sudden SSNHL have no identifiable cause for hearing loss and are classified as "idiopathic". Despite extensive research, the etiology and therapeutic management of SSNHL and acute VCS remain elusive. Regardless of the etiology, complete or partial recovery of hearing thresholds following SSNHL may not occur. Factors influencing hearing recovery include the age at onset of hearing loss, severity and frequencies affected, the presence of vertigo, and the delay of treatment. The incidence of SSNHL is 5-20 per 100, 000. The true incidence of SSNHL may be higher than these estimates because affected individuals who recover spontaneously do not present for medical care. Although individuals of all ages can be affected, the peak incidence is between the fifth and sixth decade of life. Men and women are equally affected. Nearly all cases of SSNHL are unilateral; less than 2% of patients have bilateral involvement and typically bilateral involvement is sequential. Accompanying symptoms include tinnitus (41% to 90%) and dizziness (29% to 56%) New vestibular function assessment now allows us to specify the vestibular damage associated with SSNHL. Until now, the association with dizziness was a poor prognostic factor for hearing. In a recent study in 2023, more than 60% of patients treated for SSNHL had associated vestibular damage even if they did not complain of vestibular symptoms. 20. Vestibular involvement has often been under-diagnosed and could be a way of targeting more precisely the pathophysiological mechanisms behind SSNHL. Vestibular and cochlear damage can be secondary to a pressure disorder of the endolymphatic system (endolymphatic atelectasis or endolymphatic hydrops) or to microvascular damage of cochlear and/or vestibular arteries (e.g. cochlear artery syndrome), but also to inflammatory damage of the labyrinth. 3D-Flair Endolymph magnetic resonance imaging highlighted the different mechanisms involved in deafness: endolymphatic hydrops or atelectasis, microvascular or inflammatory involvement the presence or absence of a rupture of the blood-labyrinth barrier. For all these disorders, increase serum homocysteine and plasma serotonin levels would be a predisposing factor, weakening the microvascularisation inner ear's vascular endothelium.

Conditions

Sudden Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Investigational medicinal products

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

Group Type: EXPERIMENTAL

Aspirin + Acid folic

Intervention Type: DRUG

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

Comparator treatment

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

Group Type: PLACEBO_COMPARATOR

Placebo Aspirin + Placebo Acid folic

Intervention Type: DRUG

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

Interventions

Aspirin + Acid folic

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

Intervention Type: DRUG

Placebo Aspirin + Placebo Acid folic

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lariboisière Hospital

Paris, Île-de-France Region, France

Countries

France

Central Contacts

Charlotte HAUTEFORT, Dr

Role: CONTACT

charlotte.hautefort@aphp.fr

0149958062

Ludovic DROUET

Role: CONTACT

ludovic.drouet-ext@aphp.fr

0149956414

Facility Contacts

Charlotte HAUTEFORT, Dr

Role: primary

charlotte.hautefort@aphp.fr

0149958062

Other Identifiers

2024-513710-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP230836

Identifier Type: -

Identifier Source: org_study_id