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:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Ear Infections Hearing Disorders and Deafness

U.S. FDA Resources

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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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