Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss.

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE BESANCON · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether taking oral corticosteroids (a type of anti-inflammatory medicine) helps people recover hearing after a sudden, unexplained loss of hearing in one ear. This condition, called Idiopathic Sudden Sensorineural Hearing Loss (ISSHL), happens quickly and can sometimes improve on its own, but doctors aren’t sure if corticosteroids really make a difference. The study will compare two groups of patients: one will take the steroid pills, and the other will not receive any treatment at first. If hearing doesn’t improve early on, both groups may receive steroid injections directly into the ear as a backup treatment.

Adults who have experienced sudden hearing loss in one ear within the past 10 days might be eligible, as long as the loss is confirmed by a hearing test and they don’t have other ear problems or health issues that would prevent them from safely taking steroids. Participants will be randomly assigned to either the treatment or no-treatment group and will be closely monitored to see how their hearing and any ringing in the ears (tinnitus) change over about a week to ten days. The goal is to find out if oral corticosteroids are truly helpful and to provide clearer guidance for treating this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women at least 18 years of age
• • ISSNH: idiopathic unilateral sensorineural hearing loss occurring in less than 72 hours, with loss of at least 30dB on 3 consecutive frequencies compared with the norm or the contralateral ear, confirmed on audiogram.
• • Hearing loss beginning no more than 10 days ago
• • Signed informed consent indicating that the subject has understood the purpose and procedures of the study, and agrees to participate in the study and to abide by its requirements and restrictions
• • Affiliation with a French social security scheme or beneficiary of such a scheme
• Exclusion Criteria:
• • Otological medical history, illness or treatment affecting hearing
• • Pregnancy
• • Recurrent ISSNH
• • Contraindication to oral corticosteroids or already treated with long-term corticosteroids
• • Neurological symptoms other than vertigo or tinnitus
• • Persons deprived of liberty by judicial or administrative decision; persons under forced psychiatric care; persons admitted to a health or social establishment for purposes other than research.
• • Adults under legal protection or unable to express their consent
• • Subjects who have been excluded from another study or who are on the "national volunteer list".
• • Exclusion criteria during the course of the study : discovery of vestibular schwannoma, or other pathology explaining the SUB, on MRI centered on the internal auditory canals and cerebellopontine angles prescribed as part of routine care.