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Clinical Trials/NCT04709146
NCT04709146UnknownNot Applicable

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

HaEmek Medical Center, Israel0 sites70 target enrollmentStarted: March 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
70
Primary Endpoint
sensoneural hearing level - PTA

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

sensoneural hearing level - PTA

Time Frame: through study completion, an average of 1 year

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 Outcomes

  • vestibular function(through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yoni Evgeni Gutkovich

M.D/Ph.D.

HaEmek Medical Center, Israel

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