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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04791930
Collaborator
(none)
50
1
23.1
2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Vestibular Function in Patients With Chronic Suppurative Otitis Media: Safe Type
    Anticipated Study Start Date :
    Oct 28, 2021
    Anticipated Primary Completion Date :
    Apr 28, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Vestibular evaluation [Baseline]

      The incidence and extent of vestibular dysfunction in patients with chronic suppurative otitis media: safe type

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit University Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Ahmed Abd Elhameed Ali, Principle Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04791930
    Other Study ID Numbers:
    • VNG&C.S.O.M
    First Posted:
    Mar 10, 2021
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Mohamed Ahmed Abd Elhameed Ali, Principle Investigator, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2021