Sudden Deafness Treatment Trial
SSNHL
Sudden Hearing Loss Multicenter Treatment Trial
3 other identifiers
interventional
255
1 country
14
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 hearing loss affecting one ear that occurs over less than 72 hours).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2004
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2004
CompletedFirst Posted
Study publicly available on registry
November 24, 2004
CompletedStudy Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 4, 2013
CompletedApril 4, 2017
April 1, 2017
4.8 years
November 23, 2004
November 8, 2012
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hearing Improvement
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
2 months
Study Arms (2)
1
OTHERNineteen days of oral prednisone
2
EXPERIMENTALFour doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
Interventions
Four intratympanic injections delivered to the middle ear over 2 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
House Ear Institute
Los Angeles, California, 90057, United States
University of California San Diego
San Diego, California, 92103-8895, United States
University of Florida, College of Medicine
Gainesville, Florida, 32610, United States
University of Iowa
Iowa City, Iowa, 52242-1078, United States
Johns Hopkins University
Baltimore, Maryland, 21287-0910, United States
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109-0312, United States
Michigan Ear Institute
Farmington Hills, Michigan, 48334, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
New York University School of Medicine
New York, New York, 10016, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (2)
Halpin C, Shi H, Reda D, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Slattery WH, Telian SA, Vrabec JT, Rauch S. Audiology in the sudden hearing loss clinical trial. Otol Neurotol. 2012 Aug;33(6):907-11. doi: 10.1097/MAO.0b013e31825d9a44.
PMID: 22805100DERIVEDRauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.
PMID: 21610239DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Steven Rauch
- Organization
- Massachusetts Eye and Ear Infirmary
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Rauch, MD
Massachusetts Eye and Ear Infirmary
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Otology and Laryngology, Harvard Medical School
Study Record Dates
First Submitted
November 23, 2004
First Posted
November 24, 2004
Study Start
December 1, 2004
Primary Completion
October 1, 2009
Study Completion
March 1, 2011
Last Updated
April 4, 2017
Results First Posted
April 4, 2013
Record last verified: 2017-04