Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Oral corticosteroids (OCS) are commonly used as first-line therapy, although they may have short-term side effects. Intratympanic corticosteroid injections (ITCIs) are an option for patients with contraindications to OCS or as a salvage treatment. The most recent Cochrane review includes three placebo-controlled studies on OCS efficacy (totaling 267 patients): two found no superiority of OCS, while one showed improvement in hearing. These studies are inconsistent and present methodological biases. Therefore, a sufficiently powered study is needed to assess OCS efficacy and establish clear treatment recommendations for ISSHL.
Objectives: Primary Objective: To demonstrate the equivalence of OCS as first-line treatment for ISSHL compared to no treatment, in terms of hearing recovery between days 7 and 10. Secondary Objectives: To assess the effect of OCS versus no treatment on tinnitus, and hearing recovery based on initial severity of ISSHL. To evaluate hearing recovery in patients treated with rescue ITCIs. In the absence of equivalence, to investigate the superiority of OCS over no treatment.
Methods: This multicenter, randomized, controlled equivalence trial will include two arms, each with 215 patients: one receiving OCS and the other a no-treatment control. In the absence of early hearing improvement, ITCIs will be administered regardless of study arm.
Perspective: The goal is to clarify the role of OCS in treating ISSHL and guide the development of updated treatment recommendations.
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
Otological medical history, illness or treatment affecting hearing
Pregnancy
Recurrent ISSNH
Contraindication to oral corticosteroids or already treated with long-term corticosteroids
Parallel
prednisone - oral corticosteroid 1mg/kg/D for 1 week
DrugStudy of the Standard of care versus Placebo
Placebo
DrugControl
Early hearing recovery
Hearing recovery defined by (composite criterion) : * Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB, * or \> 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
Medium-term hearing recovery
Medium-term hearing recovery: * Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB, * or \> 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
Tinnitus handicap
Change in tinnitus-related disability assessed by the Tinnitus Handicap Index (THI) score between inclusion and D10, M1, and M3.
Medium-term hearing recovery in patients without early recovery and treated with salvage trans-tympanic injections.
Hearing recovery defined by (composite criterion) : * Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB * or \> 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
Subgroup analysis based on initial severity
Subgroup analysis according to initial PTA ≥ 70dB or \<70dB
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Centre Hospitalier Universitaire de Besancon
Lead sponsor
Hôpital Civil de Strasbourg
Collaborator
CHU de Reims
Collaborator
Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
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