Sudden Deafness Treatment Trial (SSNHL)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Sudden Deafness |
Drug: prednisone Drug: methylprednisolone sodium succinate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sudden Hearing Loss Multicenter Treatment Trial |
- Hearing Improvement [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
| Enrollment: | 255 |
| Study Start Date: | December 2004 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Nineteen days of oral prednisone
|
Drug: prednisone
Oral, 19 days
|
|
Experimental: 2
Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
|
Drug: methylprednisolone sodium succinate
Four intratympanic injections delivered to the middle ear over 2 weeks
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| House Ear Institute | |
| Los Angeles, California, United States, 90057 | |
| University of California San Diego | |
| San Diego, California, United States, 92103-8895 | |
| United States, Florida | |
| University of Florida, College of Medicine | |
| Gainesville, Florida, United States, 32610 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242-1078 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-0910 | |
| United States, Massachusetts | |
| Massachusetts Eye & Ear Infirmary | |
| Boston, Massachusetts, United States, 02114 | |
| University of Massachusetts Medical School | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-0312 | |
| Michigan Ear Institute | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| New York Eye and Ear Infirmary | |
| New York, New York, United States, 10003 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Steven Rauch, MD | Massachusetts Eye and Ear Infirmary |
More Information
Additional Information:
No publications provided by Massachusetts Eye and Ear Infirmary
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT00097448 History of Changes |
| Other Study ID Numbers: | DC006296, U01DC006296, 03-11-055 |
| Study First Received: | November 23, 2004 |
| Results First Received: | November 8, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Massachusetts Eye and Ear Infirmary:
|
sudden hearing loss unilateral sudden sensorineural hearing loss sudden sensorineural hearing loss sudden unilateral hearing loss |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Hearing Loss, Sudden Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone |
Prednisone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids |
ClinicalTrials.gov processed this record on June 18, 2013