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

Primary Purpose

Otitis Media, Conductive Hearing Loss

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Ear Popper

About this trial

This is an interventional treatment trial for Otitis Media focused on measuring Effusion, Otitis, Media, Ear, Popper, Children

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ENT Unit, Dana Children's Hospital, Tel-Aviv Medical CenterRecruiting

Outcomes

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

Full Information

NCT ID

NCT00393159

First Posted

October 24, 2006

Last Updated

October 24, 2006

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00393159

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

October 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media, Conductive Hearing Loss

Keywords

Effusion, Otitis, Media, Ear, Popper, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Ear Popper

Primary Outcome Measure Information:

Title

Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.

Title

Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.

Secondary Outcome Measure Information:

Title

Hearing improvement at 7 weeks and 3 months from the beginning of the trial.

Title

Rate of referrals for tympanostomy tube insertion at 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yael Oestreicher, MD

Phone

972-3-6974517

dkyo@barak-online.net.il

First Name & Middle Initial & Last Name or Official Title & Degree

Ari DeRowe, MD

Phone

972-3-6974517

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yael Oestreicher, MD

Organizational Affiliation

Tel Aviv Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center

City

Tel-Aviv

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yael Oestreicher, MD

Phone

972-3-6974517

dkyo@barak-online.net.il

First Name & Middle Initial & Last Name & Degree

Yael Oestreicher, MD

12. IPD Sharing Statement

Learn more about this trial

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

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