MedDataX Logo

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

NCT ID: NCT00393159

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Otitis Media Conductive Hearing Loss

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Effusion Otitis Media Ear Popper Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ear Popper

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yael Oestreicher, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Tel Aviv, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yael Oestreicher, MD

Role: CONTACT

Phone: 972-3-6974517

Email: [email protected]

Ari DeRowe, MD

Role: CONTACT

Phone: 972-3-6974517

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yael Oestreicher, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TASMC06YO3567CTIL

Identifier Type: -

Identifier Source: org_study_id