Clinical trial NCT00097448: Sudden Deafness Treatment Trial
Official title: Sudden Hearing Loss Multicenter Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sudden Deafness
Keywords: sudden hearing loss
unilateral sudden sensorineural hearing loss
sudden sensorineural hearing loss
sudden unilateral hearing loss
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2004-11-24
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hearing Improvement
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Gainesville
country: United States
facility: University of Florida, College of Medicine
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye & Ear Infirmary
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Ear Institute
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Steven Rauch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.