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The Influence of Covid-19 on the Audio-vestibular System

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audio-Vestibular evaluation
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 18-80 performed audiometry testing in the last two years

Exclusion Criteria:

  • known inner ear dysfunction - Sudden sensorineural hearing loss; autoimmune disease (Cogan's syndrom, SLE, ect.), familial/genetic sensorineural hearing loss, excessive noise exposure.

knowm conductive hearing loss (Air-bone gap>10dB) prior ear surgery chronic tympanic membrane perforation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Recovered Covid-19 patients

    Healthy Control

    Arm Description

    Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.

    Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.

    Outcomes

    Primary Outcome Measures

    sensoneural hearing level - PTA
    PTA at each frequency will be compared between new and baseline audiogram for each group. Afterwhich - the average PTA decreament would be compared betwenn both groups - contrl and recovered COVID-19 patients

    Secondary Outcome Measures

    vestibular function
    vestibular function will be compared netween the two groups after VHIT, SVV and VNG testing

    Full Information

    First Posted
    January 11, 2021
    Last Updated
    January 13, 2021
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04709146
    Brief Title
    The Influence of Covid-19 on the Audio-vestibular System
    Official Title
    The Influence of Covid-19 on the Audio-vestibular System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    February 28, 2022 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    the study's porpuse is to examine whether Covid-19 causese a reduction in sensorineural hearing and vestibular function in recovered pateints - compared to healthy controls. Both study groups will undergo audiometry, tympanometry, Video Head Impulse testing, Subjective Visual Vertigo testing and Video-Nystamography. Previous audiometry results will also be aquired.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Recovered Covid-19 patients
    Arm Type
    Other
    Arm Description
    Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
    Arm Title
    Healthy Control
    Arm Type
    Other
    Arm Description
    Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Audio-Vestibular evaluation
    Intervention Description
    Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
    Primary Outcome Measure Information:
    Title
    sensoneural hearing level - PTA
    Description
    PTA at each frequency will be compared between new and baseline audiogram for each group. Afterwhich - the average PTA decreament would be compared betwenn both groups - contrl and recovered COVID-19 patients
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    vestibular function
    Description
    vestibular function will be compared netween the two groups after VHIT, SVV and VNG testing
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ages 18-80 performed audiometry testing in the last two years Exclusion Criteria: known inner ear dysfunction - Sudden sensorineural hearing loss; autoimmune disease (Cogan's syndrom, SLE, ect.), familial/genetic sensorineural hearing loss, excessive noise exposure. knowm conductive hearing loss (Air-bone gap>10dB) prior ear surgery chronic tympanic membrane perforation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yoni Evgeni Gutkovich, M.D/Ph.D
    Phone
    +972-526894497
    Email
    yonigo@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miki Paker, M.D
    Email
    miki_pa@clalit.org.il

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Influence of Covid-19 on the Audio-vestibular System

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