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
Sponsor:
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
  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
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

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

No publications provided

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:
Otitis Media
Deafness
Hearing Loss
Hearing Loss, Conductive
Otitis
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014