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

NCT07067801 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025/968
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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

Keywords

Sudden Sensorineural Hearing Loss; Corticosteroids; Randomized clinical trial; Placebo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Medium-term hearing recovery

  At 1 month and 3 months after enrollment

• Tinnitus handicap

  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.

  At 1 month and 3 months after enrollment

• Subgroup analysis based on initial severity

  At 10 days, 1 month and 3 months after enrollment

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug: Placebo

Oral Corticosteroid

EXPERIMENTAL

Standard of care

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

Interventions

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

Study of the Standard of care versus Placebo

Oral Corticosteroid

Placebo DRUG

Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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".

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Hôpital Civil de Strasbourg: collaborator
• CHU de Reims: collaborator
• Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent TAVERNIER, MD PhD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joackim MAHDJOUB, MD MSc

CONTACT

+33381218988; jmahdjoub@chu-besancon.fr

Jeanne VALET

CONTACT

+33381218988; jvalet@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled versus placebo, double-blind clinical trial

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be shared at the end of the study (\> 3 years from now)
• Access Criteria: IPD will be accessible upon request to the investigators of the study.

Locations

FR (1)