- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393159
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
October 24, 2006 updated by: Tel-Aviv Sourasky Medical Center
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yael Oestreicher, MD
- Phone Number: 972-3-6974517
- Email: dkyo@barak-online.net.il
Study Contact Backup
- Name: Ari DeRowe, MD
- Phone Number: 972-3-6974517
Study Locations
-
-
-
Tel-Aviv, Israel
- Recruiting
- ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center
-
Contact:
- Yael Oestreicher, MD
- Phone Number: 972-3-6974517
- Email: dkyo@barak-online.net.il
-
Principal Investigator:
- Yael Oestreicher, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
|
Rate of referrals for tympanostomy tube insertion at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yael Oestreicher, MD, Tel Aviv Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Registration Dates
First Submitted
October 24, 2006
First Submitted That Met QC Criteria
October 24, 2006
First Posted (Estimate)
October 26, 2006
Study Record Updates
Last Update Posted (Estimate)
October 26, 2006
Last Update Submitted That Met QC Criteria
October 24, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC06YO3567CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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