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| Name | Class |
|---|---|
| Hôpital Civil de Strasbourg | UNKNOWN |
| CHU de Reims | OTHER |
| Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France | UNKNOWN |
| Centre Hospitalier Universitaire Dijon |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| Oral Corticosteroid | Experimental | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone - oral corticosteroid 1mg/kg/D for 1 week | Drug | Study of the Standard of care versus Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early hearing recovery | Hearing recovery defined by (composite criterion) :
| From enrollment to 10 +/- 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Medium-term hearing recovery | Medium-term hearing recovery:
| At 1 month and 3 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joackim MAHDJOUB, MD MSc | Contact | +33381218988 | jmahdjoub@chu-besancon.fr | |
| Jeanne VALET | Contact | +33381218988 | jvalet@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent TAVERNIER, MD PhD | CHU de Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25000 | France |
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IPD will be shared at the end of the study (> 3 years from now)
IPD will be accessible upon request to the investigators of the study.
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C007792 | Fumigant 93 |
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| OTHER |
Randomized, controlled versus placebo, double-blind clinical trial
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| Placebo | Drug | Control |
|
| 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) :
| 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 |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |