Trials / Unknown
UnknownNCT00393159
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- Tel-Aviv Sourasky Medical Center · Other Government
- Sex
- All
- Age
- 3 Years – 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ear Popper |
Timeline
- Start date
- 2006-10-01
- First posted
- 2006-10-26
- Last updated
- 2006-10-26
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00393159. Inclusion in this directory is not an endorsement.