Study 20 of 83 for search of: "Deafness"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
This study is currently recruiting participants.
Verified by Tel-Aviv Sourasky Medical Center, October 2006
Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00393159
  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 IV

Genetics Home Reference related topics: nonsyndromic deafness
MedlinePlus related topics: Ear Infections Hearing Disorders and Deafness
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

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
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

Study ID Numbers: TASMC06YO3567CTIL
Study First Received: October 24, 2006
Last Updated: October 24, 2006
ClinicalTrials.gov Identifier: NCT00393159  
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Effusion
Otitis
Media
Ear
Popper
Children

Study placed in the following topic categories:
Sensation Disorders
Otorhinolaryngologic Diseases
Conductive hearing loss
Otitis Media with Effusion
Retrocochlear Diseases
Otitis Media
Hearing Loss, Conductive
Ear Diseases
Signs and Symptoms
Deafness
Hearing Disorders
Otitis
Neurologic Manifestations
Hearing Loss

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009