The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children|
- Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
- Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.
- Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
- Rate of referrals for tympanostomy tube insertion at 3 months
|Study Start Date:||October 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393159
|Contact: Yael Oestreicher, MDfirstname.lastname@example.org|
|Contact: Ari DeRowe, MD||972-3-6974517|
|ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center||Recruiting|
|Contact: Yael Oestreicher, MD 972-3-6974517 email@example.com|
|Principal Investigator: Yael Oestreicher, MD|
|Principal Investigator:||Yael Oestreicher, MD||Tel Aviv Medical Center|