Sudden Deafness Treatment Trial

Last updated: April 3, 2017
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Completed

Phase

3

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

N/A

Clinical Study ID

NCT00097448
DC006296
U01DC006296
03-11-055
  • Ages > 18
  • All Genders

Study 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 hearing loss affecting one ear that occurs over less than 72 hours).

Eligibility Criteria

Inclusion

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, withthe affected ear >/= 30 dB worse than contralateral ear in at least one of the fourfrequencies

  • 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

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

Study Design

Total Participants: 255
Study Start date:
December 01, 2004
Estimated Completion Date:
March 31, 2011

Study 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.

Connect with a study center

  • House Ear Institute

    Los Angeles, California 90057
    United States

    Site Not Available

  • University of California San Diego

    San Diego, California 92103-8895
    United States

    Site Not Available

  • University of Florida, College of Medicine

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242-1078
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287-0910
    United States

    Site Not Available

  • Massachusetts Eye & Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Massachusetts Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109-0312
    United States

    Site Not Available

  • Michigan Ear Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • New York Eye and Ear Infirmary

    New York, New York 10003
    United States

    Site Not Available

  • New York University School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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