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

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ClinicalTrials.gov Identifier: NCT00393159
Recruitment Status : Unknown
Verified October 2006 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : October 26, 2006
Last Update Posted : October 26, 2006
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Otitis Media Conductive Hearing Loss Device: Ear Popper Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
  2. Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.

Secondary Outcome Measures :
  1. Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
  2. Rate of referrals for tympanostomy tube insertion at 3 months

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393159


Contacts
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Contact: Yael Oestreicher, MD 972-3-6974517 dkyo@barak-online.net.il
Contact: Ari DeRowe, MD 972-3-6974517

Locations
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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
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Principal Investigator: Yael Oestreicher, MD Tel Aviv Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00393159    
Other Study ID Numbers: TASMC06YO3567CTIL
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: October 26, 2006
Last Verified: October 2006
Keywords provided by Tel-Aviv Sourasky Medical Center:
Effusion
Otitis
Media
 Ear
Popper
Children
Additional relevant MeSH terms:
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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