The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

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Brief Title

The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.

Secondary Outcome

 Hearing improvement at 7 weeks and 3 months from the beginning of the trial.

Condition

Otitis Media

Intervention

Ear Popper


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

October 2006



Eligibility 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
      

Gender

All

Ages

3 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Yael Oestreicher, MD, 972-3-6974517, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00393159

Organization ID

TASMC06YO3567CTIL



Study Sponsor

Tel-Aviv Sourasky Medical Center


Study Sponsor

Yael Oestreicher, MD, Principal Investigator, Tel Aviv Medical Center


Verification Date

October 2006