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

Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss; a Randomized, Double Blind, Futility (Non-superiority) Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sudden Sensorineural Hearing Loss
• Intervention / Treatment: Drug: Placebo; Drug: prednisone - oral corticosteroid 1mg/kg/D for 1 week

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Joackim MAHDJOUB, MD MSc; Phone Number: +33381218988; Email: jmahdjoub@chu-besancon.fr
• Study Contact Backup: Name: Jeanne VALET; Phone Number: +33381218988; Email: jvalet@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • CHU de Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: Placebo; Control
Experimental: Oral Corticosteroid; Standard of care	Drug: prednisone - oral corticosteroid 1mg/kg/D for 1 week; Study of the Standard of care versus Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to 10 +/- 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 1 month and 3 months after enrollment
Tinnitus handicap	Change in tinnitus-related disability assessed by the Tinnitus Handicap Index (THI) score between inclusion and D10, M1, and M3.	At 10 days, 1 month and 3 months after enrollment
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	At 1 month and 3 months after enrollment
Subgroup analysis based on initial severity	Subgroup analysis according to initial PTA ≥ 70dB or <70dB	At 10 days, 1 month and 3 months after enrollment

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Centre Hospitalier Universitaire Dijon; CHU de Reims; Hôpital Civil de Strasbourg; Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France
• Investigators: Principal Investigator: Laurent TAVERNIER, MD PhD, CHU de Besançon

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: July 7, 2025
• First Posted (Actual): July 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Placebo; Corticosteroids; Sudden Sensorineural Hearing Loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Unilateral; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 2025/968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: IPD will be shared at the end of the study (> 3 years from now)
• IPD Sharing Access Criteria: IPD will be accessible upon request to the investigators of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No