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

NCT ID: NCT07067801

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Sudden Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Control

Oral Corticosteroid

Standard of care

Group Type: EXPERIMENTAL

prednisone - oral corticosteroid 1mg/kg/D for 1 week

Intervention Type: DRUG

Study of the Standard of care versus Placebo

Interventions

prednisone - oral corticosteroid 1mg/kg/D for 1 week

Study of the Standard of care versus Placebo

Intervention Type: DRUG

Placebo

Control

Intervention Type: DRUG

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".

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Civil de Strasbourg

UNKNOWN

Sponsor Role: collaborator

CHU de Reims

OTHER

Sponsor Role: collaborator

Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent TAVERNIER, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

CHU de Besançon

Besançon, , France

Countries

France

Central Contacts

Joackim MAHDJOUB, MD MSc

Role: CONTACT

jmahdjoub@chu-besancon.fr

+33381218988

Jeanne VALET

Role: CONTACT

jvalet@chu-besancon.fr

+33381218988

Other Identifiers

2025/968

Identifier Type: -

Identifier Source: org_study_id