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NCT Number: NCT07067801

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Study of the Standard of care versus Placebo

Placebo

Drug

Control

Primary outcomes

  1. Early hearing recovery

    Time frame: From enrollment to 10 +/- 2 days

    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

Secondary outcomes

  1. Medium-term hearing recovery

    Time frame: At 1 month and 3 months after enrollment

    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

  2. Tinnitus handicap

    Time frame: At 10 days, 1 month and 3 months after enrollment

    Change in tinnitus-related disability assessed by the Tinnitus Handicap Index (THI) score between inclusion and D10, M1, and M3.

  3. Medium-term hearing recovery in patients without early recovery and treated with salvage trans-tympanic injections.

    Time frame: At 1 month and 3 months after enrollment

    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

  4. Subgroup analysis based on initial severity

    Time frame: At 10 days, 1 month and 3 months after enrollment

    Subgroup analysis according to initial PTA ≥ 70dB or <70dB

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanne VALET

CONTACT

[email protected]

+33381218988

Joackim MAHDJOUB, MD MSc

CONTACT

[email protected]

+33381218988

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ECOSUB

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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