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Study of Aspirin and Folic Acid Treatment for Patients with Sudden Sensorineural Hearing Loss

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Sudden Sensorineural Hearing Loss (SSNHL), a condition where hearing suddenly decreases within 72 hours, affecting at least three consecutive frequencies in one ear. The hearing loss must be at least 30 decibels in severity and have no known cause. The study aims to determine if a combination of two medications can improve hearing in people with this condition.

The treatment being tested combines Aspirin Protect (100 mg daily) and Folic Acid (5 mg daily). Some participants will receive these medications, while others will receive a placebo version of one or both medications. The study will track changes in hearing ability over time, particularly focusing on the improvement in hearing after 15 days of treatment.

Participants will be monitored for changes in their hearing through various tests over a period of 6 months. The study will measure hearing improvement, speech understanding, balance function, and quality of life. Regular check-ups will occur at specific intervals throughout the study period to assess how well the treatment is working.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your hearing condition will be evaluated to confirm sudden sensorineural hearing loss (SSNHL), which means a sudden decrease in hearing that occurred within the last 72 hours to 15 days

    A hearing test (pure-tone audiogram) will be performed to measure the extent of hearing loss

    The test will check if your hearing loss is at least 30 decibels across three consecutive frequencies

  2. Step 2

    Treatment initiation

    You will receive either:

    - Aspirin Protect 100mg tablet once daily and Folic Acid 5mg tablet once daily

    - Or placebo tablets (tablets that look the same but contain no active medicine)

    All tablets should be taken by mouth

  3. Step 3

    Day 15 evaluation

    Your hearing will be tested again to measure any changes

    Your ability to understand speech will be evaluated

    You will complete quality of life questionnaires

    Your balance function will be assessed

  4. Step 4

    3-month follow-up

    Another hearing test will be performed

    Speech understanding will be evaluated

    You will complete the same quality of life questionnaires

    Balance function will be checked again

  5. Step 5

    6-month final evaluation

    Final hearing test will be conducted

    Final speech understanding evaluation

    Final quality of life questionnaires

    Final balance function assessment

    This will conclude your participation in the study

Who can join the trial?

12 criteria

  • Patient must be between 18 and 80 years old
  • Patient must have sudden hearing loss that:
    • Affects only one ear
    • Occurred within the last 15 days
    • Developed within 72 hours (3 days)
    • Shows a decrease in hearing of at least 30 decibels (a measure of sound intensity) in at least three connected frequencies during a hearing test
    • Patient must be registered with a social security system
    • Patient must be able to:
      • Participate in all study activities
      • Attend all follow-up appointments during the study period
      • Patient must not have:
        • Any neurological symptoms except hearing loss
        • Any history of fluctuating hearing loss
        • Any previous ear diseases
        • Conductive hearing loss (hearing loss related to problems in outer or middle ear)

Who cannot join the trial?

9 criteria

  • Hearing loss that has lasted longer than 15 days or less than 72 hours
  • Hearing loss that affects both ears (must be only one ear)
  • History of fluctuating hearing loss (hearing that goes up and down over time)
  • Previous ear diseases or disorders
  • Presence of conductive hearing loss (problems with sound reaching the inner ear through the ear canal)
  • Neurological symptoms other than those related to the eighth cranial nerve (the nerve responsible for hearing and balance)
  • Hearing loss less than 30 decibels across 3 consecutive frequencies (must be greater than this threshold)
  • Known cause of hearing loss (must be idiopathic, meaning the cause is unknown)
  • History of other ear-related conditions that could affect hearing
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Investigated drugs

  • Aspirin

    is a commonly used medication that helps reduce inflammation and prevent blood clots. In this trial, it is being studied for its potential benefits in treating sudden hearing loss. It works by reducing inflammation in the inner ear and improving blood flow to the hearing structures.

  • Folic Acid

    is a B-vitamin that plays an important role in cell growth and DNA synthesis. In this trial, it is being investigated alongside aspirin to help improve hearing recovery in patients with sudden hearing loss. It may help support the healing and regeneration of damaged hearing cells.

What is already known about the treatment

  • Aspirin

    A widely used antiplatelet medication administered orally in tablet form, in this trial used at 100mg daily dose for sudden sensorineural hearing loss (SSNHL). It works by inhibiting platelet aggregation and reducing inflammation through blocking cyclooxygenase enzymes, potentially improving blood flow to the inner ear. This medication belongs to the nonsteroidal anti-inflammatory drugs (NSAIDs) class and is being studied for its potential benefits in treating sudden hearing loss due to its blood-thinning and anti-inflammatory properties.

  • Folic Acid

    A B-vitamin supplement administered orally in tablet form, used at 5mg daily dose in this trial for sudden sensorineural hearing loss treatment. It plays a crucial role in cell growth and DNA synthesis, and may help improve blood circulation and cellular repair in the inner ear. This water-soluble vitamin is classified as a nutritional supplement and is being investigated for its potential therapeutic benefits in hearing loss, possibly through its role in maintaining healthy blood vessels and reducing homocysteine levels.

Investigated diseases

Sudden Sensorineural Hearing Loss (SSNHL) - A condition characterized by a rapid loss of hearing that occurs over a period of up to 72 hours, affecting only one ear. It involves a decrease in hearing of 30 decibels or more across at least three consecutive frequencies. The condition specifically affects the inner ear or nerve pathways from the inner ear to the brain. SSNHL is considered idiopathic, meaning its exact cause is often unknown. The condition occurs without any prior history of hearing problems or ear diseases, and presents without other neurological symptoms except those related to the eighth cranial nerve.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513710-35-00Protocol codeAPHP230836Estimated enrolment142 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).