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Trial record 11 of 714 for:    Deafness

Sudden Deafness Treatment Trial (SSNHL)

This study has been completed.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Steven Rauch, MD, Massachusetts Eye and Ear Infirmary Identifier:
First received: November 23, 2004
Last updated: April 3, 2017
Last verified: April 2017
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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Sudden Hearing Loss Multicenter Treatment Trial

Resource links provided by NLM:

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Hearing Improvement [ Time Frame: 2 months ]
    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
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


  • >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


  • 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
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Please refer to this study by its identifier: NCT00097448

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 Eye and Ear Infirmary
New York, New York, United States, 10003
New York University School of Medicine
New York, New York, United States, 10016
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Steven Rauch, MD Massachusetts Eye and Ear Infirmary
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven Rauch, MD, Professor of Otology and Laryngology, Harvard Medical School, Massachusetts Eye and Ear Infirmary Identifier: NCT00097448     History of Changes
Other Study ID Numbers: DC006296
U01DC006296 ( US NIH Grant/Contract Award Number )
03-11-055 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
Study First Received: November 23, 2004
Results First Received: November 8, 2012
Last Updated: April 3, 2017

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:
Hearing Loss
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents processed this record on April 28, 2017