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NCT04709146 Clinical Trial

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

Covid19 Clinical Trial

Official title:
The Influence of Covid-19 on the Audio-vestibular System

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04709146
Other study ID # 0226-20-EMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2022

Study information
Verified date January 2021
Source HaEmek Medical Center, Israel
Contact Yoni Evgeni Gutkovich, M.D/Ph.D
Phone +972-526894497
Email yonigo@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date June 30, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Audio-Vestibular evaluation
Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Outcome
Type Measure Description Time frame Safety issue
Primary 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 through study completion, an average of 1 year
Secondary vestibular function vestibular function will be compared netween the two groups after VHIT, SVV and VNG testing through study completion, an average of 1 year
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