Sudden Deafness Treatment Trial

Study Overview
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Brief Summary
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This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).

Detailed Description
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Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.

Official Title
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Sudden Hearing Loss Multicenter Treatment Trial

Conditions
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Sudden Deafness

Intervention / Treatment
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* Drug: prednisone
* Drug: methylprednisolone sodium succinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men/women 18 years and older in good health Unilateral sensorineural hearing loss developing within 72 hours (SSNHL) Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies Symmetric hearing prior to onset of SSNHL Hearing loss must be idiopathic Hearing loss must have occurred within the past 14 days Must be able to read or write English or Spanish Exclusion Criteria: SYSTEMIC DISEASE >21 days prior oral steroid treatment within preceding 30 days History of tuberculosis (TB) or positive PPD Insulin-dependent diabetes mellitus History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc. Serious psychiatric disease or psychiatric reaction to corticosteroids History of heart disease or transient ischemic attacks (TIAs) Prior treatment with chemotherapeutic or immunosuppressive drugs Pancreatitis Active peptic ulcer disease or history of gastrointestinal bleeding History of HIV, Hepatitis B or C Chronic kidney failure Alcohol abuse Active shingles Severe osteoporosis or non-surgical aseptic necrosis of the hip OTOLOGIC DISEASE Prior history of SSNHL History of fluctuating hearing loss History of Meniere's disease History of chronic ear infection History of otosclerosis History of ear surgery (except childhood pressure equalization [pe] tubes) History of congenital hearing loss History of trauma immediately preceding onset of SSNHL History of syphilitic hearing loss History of genetic/hereditary hearing loss Skull, facial, or temporal bone anomalies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Nineteen days of oral prednisone | Drug: prednisone<br>* Oral, 19 days<br>|
| Experimental: 2<br>Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks | Drug: methylprednisolone sodium succinate<br>* Four intratympanic injections delivered to the middle ear over 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Improvement | Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss