Sudden Deafness Treatment Trial (SSNHL)

Sudden Hearing Loss Multicenter Treatment Trial

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).

Study Overview

• Status: Completed
• Conditions: Sudden Deafness
• Intervention / Treatment: Drug: prednisone; Drug: methylprednisolone sodium succinate

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: Interventional
• Enrollment (Actual): 255
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Steven Rauch, MD, Massachusetts Eye and Ear Infirmary

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Sudden Deafness

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 23, 2004
• First Submitted That Met QC Criteria: November 23, 2004
• First Posted (Estimate): November 24, 2004

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: sudden hearing loss; unilateral sudden sensorineural hearing loss; sudden sensorineural hearing loss; sudden unilateral hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sudden; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone
• Other Study ID Numbers: DC006296; U01DC006296 (U.S. NIH Grant/Contract); 03-11-055 (Other Identifier: Massachusetts Eye and Ear Infirmary)