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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: October 24, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
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

Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00393159

ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Yael Oestreicher, MD Tel Aviv Medical Center
  More Information 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:

Additional relevant MeSH terms:
Hearing Loss
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 processed this record on January 17, 2017