Sudden Deafness Treatment Trial (SSNHL)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00097448
First received: November 23, 2004
Last updated: February 27, 2013
Last verified: February 2013
  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 Intervention Phase
Sudden Deafness
Drug: prednisone
Drug: methylprednisolone sodium succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sudden Hearing Loss Multicenter Treatment Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Hearing Improvement [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.


Enrollment: 255
Study Start Date: December 2004
Study Completion Date: March 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Nineteen days of oral prednisone
Drug: prednisone
Oral, 19 days
Experimental: 2
Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
Drug: methylprednisolone sodium succinate
Four intratympanic injections delivered to the middle ear over 2 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097448

Locations
United States, California
House Ear Institute
Los Angeles, California, United States, 90057
University of California San Diego
San Diego, California, United States, 92103-8895
United States, Florida
University of Florida, College of Medicine
Gainesville, Florida, United States, 32610
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242-1078
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-0910
United States, Massachusetts
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0312
Michigan Ear Institute
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Steven Rauch, MD Massachusetts Eye and Ear Infirmary
  More Information

No publications provided by Massachusetts Eye and Ear Infirmary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00097448     History of Changes
Other Study ID Numbers: DC006296, U01DC006296, 03-11-055
Study First Received: November 23, 2004
Results First Received: November 8, 2012
Last Updated: February 27, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Massachusetts Eye and Ear Infirmary:
sudden hearing loss
unilateral sudden sensorineural hearing loss
sudden sensorineural hearing loss
sudden unilateral hearing loss

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Sudden
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014