Status:
COMPLETED
Sudden Deafness Treatment Trial
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Sudden Deafness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 hea...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00097448
Start Date
December 1 2004
End Date
March 1 2011
Last Update
April 4 2017
Active Locations (14)
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1
House Ear Institute
Los Angeles, California, United States, 90057
2
University of California San Diego
San Diego, California, United States, 92103-8895
3
University of Florida, College of Medicine
Gainesville, Florida, United States, 32610
4
University of Iowa
Iowa City, Iowa, United States, 52242-1078