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Sudden Deafness Treatment Trial (SSNHL)

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ClinicalTrials.gov Identifier: NCT00097448
Recruitment Status : Completed
First Posted : November 24, 2004
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Steven Rauch, MD, Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE November 23, 2004
First Posted Date  ICMJE November 24, 2004
Results First Submitted Date  ICMJE November 8, 2012
Results First Posted Date  ICMJE April 4, 2013
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE December 2004
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2013)
Hearing Improvement [ Time Frame: 2 months ]
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Hearing Improvement
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sudden Deafness Treatment Trial
Official Title  ICMJE Sudden Hearing Loss Multicenter Treatment Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sudden Deafness
Intervention  ICMJE
  • Drug: prednisone
    Oral, 19 days
  • Drug: methylprednisolone sodium succinate
    Four intratympanic injections delivered to the middle ear over 2 weeks
Study Arms  ICMJE
  • 1
    Nineteen days of oral prednisone
    Intervention: Drug: prednisone
  • Experimental: 2
    Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
    Intervention: Drug: methylprednisolone sodium succinate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2013)
255
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
254
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00097448
Other Study ID Numbers  ICMJE DC006296
U01DC006296 ( U.S. NIH Grant/Contract )
03-11-055 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Rauch, MD, Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Steven Rauch, MD Massachusetts Eye and Ear Infirmary
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP