Sudden Deafness Treatment Trial

NCT ID: NCT00097448

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2011-03-31

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.

Conditions

Sudden Deafness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Nineteen days of oral prednisone

Group Type: OTHER

prednisone

Intervention Type: DRUG

Oral, 19 days

2

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

Group Type: EXPERIMENTAL

methylprednisolone sodium succinate

Intervention Type: DRUG

Four intratympanic injections delivered to the middle ear over 2 weeks

Interventions

prednisone

Oral, 19 days

Intervention Type: DRUG

methylprednisolone sodium succinate

Four intratympanic injections delivered to the middle ear over 2 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Steven Rauch, MD

Professor of Otology and Laryngology, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Rauch, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

House Ear Institute

Los Angeles, California, United States

University of California San Diego

San Diego, California, United States

University of Florida, College of Medicine

Gainesville, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Michigan Ear Institute

Farmington Hills, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

New York Eye and Ear Infirmary

New York, New York, United States

New York University School of Medicine

New York, New York, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22805100 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21610239 (View on PubMed)

Related Links

http://www.suddendeafness.org

Sudden Deafness

Other Identifiers

U01DC006296

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-11-055

Identifier Type: OTHER

Identifier Source: secondary_id

DC006296

Identifier Type: -

Identifier Source: org_study_id