Sudden Deafness Treatment Trial (SSNHL)
Sudden Deafness
About this trial
This is an interventional treatment trial for Sudden Deafness focused on measuring sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss
Eligibility Criteria
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
Sites / Locations
- House Ear Institute
- University of California San Diego
- University of Florida, College of Medicine
- University of Iowa
- Johns Hopkins University
- Massachusetts Eye & Ear Infirmary
- University of Massachusetts Medical School
- University of Michigan
- Michigan Ear Institute
- Washington University School of Medicine
- New York Eye and Ear Infirmary
- New York University School of Medicine
- University of Texas Southwestern Medical Center
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Other
Experimental
1
2
Nineteen days of oral prednisone
Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks