NCT00097448

Sudden Deafness Treatment Trial

Sudden Hearing Loss Multicenter Treatment Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	prednisone	Oral, 19 days
DRUG	methylprednisolone sodium succinate	Four intratympanic injections delivered to the middle ear over 2 weeks

Timeline

• Start date: 2004-12-01
• Primary completion: 2009-10-01
• Completion: 2011-03-01
• First posted: 2004-11-24
• Last updated: 2017-04-04
• Results posted: 2013-04-04

Locations

14 sites across 1 country: United States