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Sponsored by: |
Tel-Aviv Sourasky Medical Center |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00393159 |
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.
Condition | Intervention | Phase |
---|---|---|
Otitis Media Conductive Hearing Loss |
Device: Ear Popper |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children |
Estimated Enrollment: | 30 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yael Oestreicher, MD | 972-3-6974517 | dkyo@barak-online.net.il |
Contact: Ari DeRowe, MD | 972-3-6974517 |
Israel | |
ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center | Recruiting |
Tel-Aviv, Israel | |
Contact: Yael Oestreicher, MD 972-3-6974517 dkyo@barak-online.net.il | |
Principal Investigator: Yael Oestreicher, MD |
Principal Investigator: | Yael Oestreicher, MD | Tel-Aviv Medical Center |
Study ID Numbers: | TASMC06YO3567CTIL |
Study First Received: | October 24, 2006 |
Last Updated: | October 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00393159 |
Health Authority: | Israel: Ministry of Health |
Effusion Otitis Media |
Ear Popper Children |
Sensation Disorders Otorhinolaryngologic Diseases Conductive hearing loss Otitis Media with Effusion Retrocochlear Diseases Otitis Media Hearing Loss, Conductive |
Ear Diseases Signs and Symptoms Deafness Hearing Disorders Otitis Neurologic Manifestations Hearing Loss |
Nervous System Diseases |