Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097448
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2004-11-23
Brief Title:
Sudden Deafness Treatment Trial
Sponsor:
Massachusetts Eye and Ear Infirmary
Organization:
Massachusetts Eye and Ear Infirmary
Study Overview
Official Title:
Sudden Hearing Loss Multicenter Treatment Trial
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSNHL
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 15000 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 60mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-11-055 | OTHER | Massachusetts Eye and Ear Infirmary | httpsreporternihgovquickSearchU01DC006296 |
| U01DC006296 | NIH | None | None |