Sudden Deafness Treatment Trial

Completed · Phase 3

Conditions studied: Sudden Deafness

In brief

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).

Key facts

Study ID

NCT00097448

Run by

Massachusetts Eye and Ear Infirmary

People needed

255

Starts

2004-12-01

Expected to finish

2011-03-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• House Ear Institute — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• University of Florida, College of Medicine — Gainesville, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts Eye & Ear Infirmary — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Michigan Ear Institute — Farmington Hills, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• New York University School of Medicine — New York, New York, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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