Sudden Deafness Treatment Trial

Sudden Deafness Clinical Trial

— SSNHL  

Official title:

Sudden Hearing Loss Multicenter Treatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097448
• Other study ID #: DC006296
• Secondary ID: U01DC00629603-11
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2004
• Last updated: April 3, 2017
• Start date: December 2004
• Est. completion date: March 2011

Study information

• Verified date: April 2017
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: March 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sudden
• Sudden Deafness

Intervention

Drug:
• prednisone
Oral, 19 days
• methylprednisolone sodium succinate
Four intratympanic injections delivered to the middle ear over 2 weeks

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts Eye & Ear Infirmary	Boston	Massachusetts
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Michigan Ear Institute	Farmington Hills	Michigan
United States	University of Florida, College of Medicine	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	House Ear Institute	Los Angeles	California
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 California San Diego	San Diego	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

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