Evaluation of Vestibular Function in Patients With C.S.O.M: Safe Type

March 9, 2021 updated by: Mohamed Ahmed Abd Elhameed Ali, Assiut University

Evaluation of Vestibular Function in Patients With Chronic Suppurative Otitis Media: Safe Type

To evaluate the function of vestibular system in patients with chronic suppurative otitis media safe type.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Chronic suppurative otitis media (CSOM) remains one of the most common chronic infectious diseases worldwide, affecting diverse racial and cultural groups both in developing and industrialized countries. It involves considerable morbidity and can cause extra- and intracranial complications .

CSOM in all its clinical presentations (acute, serous and chronic) develops with varying degrees of lesions in the inner ear, which showing a higher prevalence of disabling hearing loss, tinnitus and balance and vestibular alterations.

In recent years, authors have raised the hypothesis that the vestibular system could also be subject to inflammatory lesions secondary to CSOM. These hypotheses were supported by clinical studies, which disclosed a high prevalence of vestibular symptoms in patients with CSOM (40% -60%), in addition to changes in several vestibular function tests (caloric testing, rotary chair, vestibular evoked myogenic potentials, vHIT and posturography) .

Over the years, several studies have analyzed the potential clinical impact of CSOM on vestibular function (Monsanto et al, 2018). However, a recent systematic review showed that these studies are mostly have had several biases identified (selection, attrition, performance and detection) .

Also, there are a number of difficulties regarding changes in vestibular function secondary to CSOM, mainly because several vestibular function tests (caloric testing, vestibular evoked myogenic potentials) do not have validated results for patients with middle ear disorders inherent to CSOM (tympanic perforation, ossicular erosion, fibrosis or secretion in the middle ear, and conductive hearing loss), and therefore are not directly comparable to those of patients without middle ear diseases.

Furthermore, CSOM is more prevalent in the elderly, who have several other possible causal factors for vestibular symptoms, therefore, directly correlating CSOM with changes in vestibular function is a challenging task .

One of the vestibular function tests of that is not significantly influenced by CSOM is the video head impulse test, this test can objectively assess the function of each one of the semicircular canals alone, providing important information regarding changes in the vestibulo-ocular reflex (VOR), despite these advantages, the literature on the use of the video head impulse test in patients with COM is very scarce. Considering the role of the head impulse test in the diagnosis of VOR alterations, the identification of alterations in this test can help in the topographic characterization of vestibular alterations secondary to COM .

Evaluation of vestibular function in patients with safe type chronic suppurative otitis media provide many strategies aimed to prevent the sequelae and give idea about selection of adequate treatment and rehabilitation .

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed Mohamed Elmoursy, Lecturer
  • Phone Number: 01003615648

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assuit University
        • Contact:
          • Mohamed Ahmed Abd Elhameed Ali
          • Phone Number: 01065276753

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

10 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic suppurative otitis media safe type.

Description

Inclusion Criteria:

  • Age: from 10 years to 45 years old.
  • Sex: male or female.
  • Safe type Chronic Suppurative Otitis Media.

Exclusion Criteria:

  • Un safe type Chronic Suppurative Otitis Media.
  • Noise exposure and heredofamilial hearing loss.
  • Adhesive process or history of ear surgery.

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: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular evaluation
Time Frame: Baseline
The incidence and extent of vestibular dysfunction in patients with chronic suppurative otitis media: safe type
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Enass sayed Mohamed, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

October 28, 2021

Primary Completion (Anticipated)

April 28, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNG&C.S.O.M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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 Vertigo Labyrinthine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe