Sudden Sensorineural Hearing Loss
Conditions
Keywords
Sudden Sensorineural Hearing Loss, Corticosteroids, Randomized clinical trial, Placebo
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.
Interventions
Study of the Standard of care versus Placebo
DRUGPlacebo
Control
Sponsors
Hôpital Civil de Strasbourg
CHU de Reims
Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, controlled versus placebo, double-blind clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early hearing recovery | 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
| Measure | Time frame | Description |
|---|---|---|
| Medium-term hearing recovery | 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 |
| Tinnitus handicap | 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. |
| Medium-term hearing recovery in patients without early recovery and treated with salvage trans-tympanic injections. | 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 |
| Subgroup analysis based on initial severity | At 10 days, 1 month and 3 months after enrollment | Subgroup analysis according to initial PTA ≥ 70dB or \<70dB |
Countries
France
Contacts
Primary ContactJoackim MAHDJOUB, MD MSc
Backup ContactJeanne VALET
Outcome results
None listed