Sudden Deafness Treatment Trial (SSNHL)

Mass Eye and Ear

Status and phase

Completed

Phase 3

Conditions

Sudden Deafness

Treatments

Drug: prednisone

Drug: methylprednisolone sodium succinate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00097448

DC006296

U01DC006296 (U.S. NIH Grant/Contract)

03-11-055 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

255 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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