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

3 1 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hopital Europeen Marseille	Marseille	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Rothschild Hospital	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.12.2025

Trial locations

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.

Investigated diseases:

Deafness

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 ID:

2024-513710-35-00

Protocol code:

APHP230836

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?