Authorised Therapeutic confirmatory (Phase III) Patients presenting to ENT emergencies with a unilateral sudden sensorineural hearing loss (SSNHL). SSNHL is defined according to the American ENT society guidelines criteria as a subset of SSNHL that is sensorineural in nature, occurs within a 72 hour window, and consists of a decrease in hearing of ≥30 decibels affecting at least 3 consecutive frequencies: 1. A history of an idiopathic and unilateral sudden decrease in hearing > 72 hours and <15 days. 2. A unilateral sensorineural hearing loss demonstrable on a pure‐tone audiogram at the time of entry into the trial. 3. No other neurological signs except the eight cranial nerve defect; no other types of hearing loss as conductive forms of hearing impairment. 4. No history of fluctuating sensorineural hearing loss or otologic disease.

SERORL Effect of aspirin and folic acid for sudden sensorineural hearing loss

EU CTIS ID: 2024-513710-35-00

What this study is testing

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.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - 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

You likely can't join if

  • Contra-indications to Aspirin,
  • - Pregnant or breastfeeding women
  • - 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
See the full eligibility criteria
Who can join
  • - 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
What rules you out
  • Contra-indications to Aspirin,
  • - Pregnant or breastfeeding women
  • - 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.