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
About this trial
This is an interventional diagnostic trial for Covid19
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.
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
NCT ID
NCT04709146
First Posted
January 11, 2021
Last Updated
January 13, 2021
Sponsor
HaEmek Medical Center, Israel
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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