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Deafness & Hearing Loss |
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Clinical Trial: Sudden Hearing Loss Multicenter Treatment Trial
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Sudden Deafness | Drug: oral prednisone Drug: intratympanic methylprednisolone | Phase III |
MedlinePlus related topics: Hearing Disorders and Deafness
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: hearing improvement
Expected Total Enrollment: 254
Expected Total Enrollment: 254
Study start: December 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Men/women 18 years and older in good health
- Unilateral sensorineural hearing loss developing within 24 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
Location and Contact Information
California
University of California San Diego, San Diego, California, 92103-8895, United States; Recruiting
Sherrie Glassmeyer, MSN, FNP 858-657-8680 sglassmeyer@ucsd.edu
Jeffrey P. Harris, MD, PhD, Principal Investigator
Jeffrey P. Harris, MD, PhD, Principal Investigator
Iowa
University of Iowa, Iowa City, Iowa, 52242-1078, United States; Recruiting
Deborah Strike, BSN, RN 319-356-3345 deborah-strike@uiowa.edu
Bruce J. Gantz, MD, Principal Investigator
Marlan R. Hansen, MD, Sub-Investigator
Bruce J. Gantz, MD, Principal Investigator
Marlan R. Hansen, MD, Sub-Investigator
Maryland
Johns Hopkins University, Baltimore, Maryland, 21287-0910, United States; Recruiting
Nancy Smith, PA-C 1-866-240-2576 (toll-free) nsmith2@jhmi.edu
John P. Carey, MD, Principal Investigator
Charles Della Santina, MD, PhD, Sub-Investigator
John P. Carey, MD, Principal Investigator
Charles Della Santina, MD, PhD, Sub-Investigator
Massachusetts
Massachusetts Eye & Ear Infirmary, Boston, Massachusetts, 02114, United States; Recruiting
Mary L. Bartley, RN, BA 1-866-573-3628 (toll-free) mary_bartley@meei.harvard.edu
Steven D. Rauch, MD, Principal Investigator
Ronald K. de Venecia, MD, PhD, Sub-Investigator
Steven D. Rauch, MD, Principal Investigator
Ronald K. de Venecia, MD, PhD, Sub-Investigator
University of Massachusetts Medical School, Worcester, Massachusetts, 01655, United States; Recruiting
Karen Longtine, BS, RN, CCRC 508-722-0546 (24/7 pager) Karen.Longtine@umassmed.edu
Daniel J. Lee, MD, Principal Investigator
Richard R. Gacek, MD, Sub-Investigator
Daniel J. Lee, MD, Principal Investigator
Richard R. Gacek, MD, Sub-Investigator
Michigan
University of Michigan, Ann Arbor, Michigan, 48109-0312, United States; Recruiting
Jeanne Guiterrez 734-936-8006 jeanneg@umich.edu
Steven A. Telian, MD, Principal Investigator
Hussam El-Kashlan, MD, Sub-Investigator
Steven A. Telian, MD, Principal Investigator
Hussam El-Kashlan, MD, Sub-Investigator
New York
New York University School of Medicine, New York, New York, 10016, United States; Recruiting
Dorline Jean, RN 212-263-7488 D.Jean@med.nyu.edu
Paul E. Hammerschlag, MD, Principal Investigator
J. Thomas Roland, MD, Sub-Investigator
Paul E. Hammerschlag, MD, Principal Investigator
J. Thomas Roland, MD, Sub-Investigator
Ohio
The Cleveland Clinic, Cleveland, Ohio, 44195, United States; Recruiting
Michelle A. Crespo, RN, BSN 216-444-5029 crespom@ccf.org
Gordon B. Hughes, MD, Principal Investigator
Peter C. Weber, MD, Sub-Investigator
Gordon B. Hughes, MD, Principal Investigator
Peter C. Weber, MD, Sub-Investigator
More Information
Study ID Numbers: DC006296
Record last reviewed: March 2005
Last Updated: March 3, 2005
Record first received: November 23, 2004
ClinicalTrials.gov Identifier: NCT00097448
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 3, 2005
Record first received: November 23, 2004
ClinicalTrials.gov Identifier: NCT00097448
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- 1999 Federal Government TTY Directory (Federal Citizen Information Center, GSA)
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