Clinical Trial: The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
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 Summary:
Sponsor: Tel-Aviv Sourasky Medical Center
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
- Rate of referrals for tympanostomy tube insertion at 3 months
Original Secondary Outcome: Same as current
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: October 24, 2006
Date Started: October 2006
Date Completion:
Last Updated: October 24, 2006
Last Verified: October 2006
