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Sudden Deafness Treatment Trial (SSNHL)

Primary Purpose

Sudden Deafness

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
prednisone
methylprednisolone sodium succinate
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Deafness focused on measuring sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • House Ear Institute
  • University of California San Diego
  • University of Florida, College of Medicine
  • University of Iowa
  • Johns Hopkins University
  • Massachusetts Eye & Ear Infirmary
  • University of Massachusetts Medical School
  • University of Michigan
  • Michigan Ear Institute
  • Washington University School of Medicine
  • New York Eye and Ear Infirmary
  • New York University School of Medicine
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

1

2

Arm Description

Nineteen days of oral prednisone

Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks

Outcomes

Primary Outcome Measures

Hearing Improvement
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2004
Last Updated
April 3, 2017
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00097448
Brief Title
Sudden Deafness Treatment Trial
Acronym
SSNHL
Official Title
Sudden Hearing Loss Multicenter Treatment Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Deafness
Keywords
sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Nineteen days of oral prednisone
Arm Title
2
Arm Type
Experimental
Arm Description
Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Oral, 19 days
Intervention Type
Drug
Intervention Name(s)
methylprednisolone sodium succinate
Intervention Description
Four intratympanic injections delivered to the middle ear over 2 weeks
Primary Outcome Measure Information:
Title
Hearing Improvement
Description
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Rauch, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
House Ear Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8895
Country
United States
Facility Name
University of Florida, College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1078
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0910
Country
United States
Facility Name
Massachusetts Eye & Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0312
Country
United States
Facility Name
Michigan Ear Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22805100
Citation
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.
Results Reference
derived
PubMed Identifier
21610239
Citation
Rauch 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.
Results Reference
derived
Links:
URL
http://www.suddendeafness.org
Description
Sudden Deafness

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Sudden Deafness Treatment Trial

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