Clinical Trial: Sudden Deafness Treatment Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sudden Hearing Loss Multicenter Treatment Trial

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 Summary: 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.
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: Hearing Improvement [ Time Frame: 2 months ]

Original Primary Outcome: Hearing Improvement

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: November 23, 2004
Date Started: December 2004
Date Completion:
Last Updated: April 3, 2017
Last Verified: April 2017