Wideband Tympanometry in Otitis Media With Effusion

September 14, 2023 updated by: Fazıl Necdet Ardıç, Pamukkale University

The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry

The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.

Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.

Study Type

Observational

Enrollment (Actual)

202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

children with otitis media with effusion

Description

Inclusion Criteria:

  • All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.

Exclusion Criteria:

  • The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 0
Patients were divided into groups according to observation in surgery Empty ear in operation
Diagnostic test: Wideband Tympanometry
Group 1
Patients were divided into groups according to observation in surgery Serous fluid in operation
Diagnostic test: Wideband Tympanometry
Group 2
Patients were divided into groups according to observation in surgery Mucoid fluid in operation
Diagnostic test: Wideband Tympanometry
Group 3
Patients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation
Diagnostic test: Wideband Tympanometry
Group 4
Control group. Subjects with no otitis media with effusion
Diagnostic test: Wideband Tympanometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resonance frequency
Time Frame: The same 1 day with the operation
Wideband resonance frequency was measured
The same 1 day with the operation
Absorbance
Time Frame: The same 1 day with the operation
Wideband absorbance of frequencies between 250-8000 Hz were measured
The same 1 day with the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Fazıl N Ardıç, MD, Chief of Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available in the university depository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Otitis Media With Effusion

Clinical Trials on Wideband Tympanometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe