Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 142 people, planned
- Started
- 1 Apr 2026
- Expected to end
- 1 Nov 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Aspirin + Acid folic
- Placebo Aspirin + Placebo Acid folic
- Record updated
- 14 January 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients taking serotonin reuptake inhibitors
- 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 already taking aspirin or other anticoagulant or antiplatelet agent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Investigational medicinal productsTreatment being tested
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
Treatment: Aspirin + Acid folic
- Comparator treatmentPlacebo, for comparison
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
Treatment: Placebo Aspirin + Placebo Acid folic
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07113158, who can take part
- Record updated
- 14 January 2026