The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00393159
First received: October 24, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
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Purpose
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 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Tel-Aviv Sourasky Medical Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
- Rate of referrals for tympanostomy tube insertion at 3 months
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2006 |
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Serous Otitis Media for More Then 3 months
- Conductive Hearing Loss of More Then 15 decibels.
- Tympanometry type B or C.
Exclusion Criteria:
- No History of Tympanostomy Tube Insertion or Adenoidectomy
- No Cranio or Facial Malformations
- No Acute Upper Respiratory Tract Infection or Acute Otitis Media
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393159
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393159
Contacts
| Contact: Yael Oestreicher, MD | 972-3-6974517 | dkyo@barak-online.net.il | |
| Contact: Ari DeRowe, MD | 972-3-6974517 |
Locations
| 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 | |
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
| Principal Investigator: | Yael Oestreicher, MD | Tel Aviv Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00393159 History of Changes |
| Other Study ID Numbers: | TASMC06YO3567CTIL |
| Study First Received: | October 24, 2006 |
| Last Updated: | October 24, 2006 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Effusion Otitis Media |
Ear Popper Children |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Otitis Otitis Media Hearing Loss, Conductive Otitis Media with Effusion Hearing Disorders |
Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 30, 2016