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Not yet recruitingPhase 3

Aspirin and folic acid for sudden hearing loss in one ear

Tests aspirin with folic acid in adults with sudden sensorineural hearing loss.

Key facts

Who runs it
Assistance Publique Hopitaux De Paris
Where
France5 sites in 1 countryChoose a country to see its sites
Registry title
SERORL Effect of aspirin and folic acid for sudden sensorineural hearing loss
Status
Not yet recruiting
Phase
Phase 3
People taking part
142 people, planned
Started
1 Dec 2025
Expected to end
1 Jun 2030
Type of study
Interventional
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with sudden hearing loss in one ear from an inner ear or nerve problem. It tests Aspirin 100mg/day and Folic Acid 5 mg/day.

Age
Older than 18 and younger than 80 years.
Sex
All sexes can join.
Disease stage
Sudden hearing loss in one ear of 30dB or more, on at least three neighbouring frequencies (between 125hz and 8000Hz). It came on within a 72 hr period and has lasted less than 15 days.
Earlier treatment
People already taking aspirin, another blood thinner or an anti-platelet drug cannot join. People taking serotonin reuptake inhibitors cannot join.
Biomarker or test result
A hearing test showing the hearing loss.

Main reasons for not taking part

  • Pregnant or breastfeeding women.
  • Cannot take aspirin, oral corticosteroids or dexamethasone, or allergy to vitamin B9.
  • A clear cause of the hearing loss, such as a tumour, inner ear infection, injury, inner ear malformation or nerve disorder.
  • Already in another clinical trial.
  • Under guardianship or curatorship.

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Age > 18 and < 80 years
  • 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

  • Contra-indications to oral corticosteroid therapy,
  • Contra-indications to dexamethasone
  • Person under legal protection (under guardianship or curatorship); -Patients taking serotonin reuptake inhibitors
  • 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
  • Contra-indications to Aspirin,
  • Pregnant or breastfeeding women
  • Patient already including in another clinical trial
  • Patients already taking aspirin or other anticoagulant or antiplatelet agent

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

To determine if an early treatment with Aspirin 100mg/day and Folic Acid 5 mg/day induces a significant improvement of the PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 in patients presenting with SSNHL.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
SERORL Effect of aspirin and folic acid for sudden sensorineural hearing loss
Plain-language title
Aspirin and folic acid for sudden hearing loss in one earGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
12 November 2026