Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 6:46 PM
Study NCT ID:
NCT00393159
Status:
UNKNOWN
Last Update Posted:
2006-10-26
First Post:
2006-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official Title:
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: