The Influence of Covid-19 on the Audio-vestibular System
January 13, 2021 updated by: Yoni Evgeni Gutkovich, HaEmek Medical Center, Israel
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Recovered Covid-19 patients
Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
|
Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
|
|
Other: Healthy Control
Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
|
Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vestibular function
Time Frame: through study completion, an average of 1 year
|
vestibular function will be compared netween the two groups after VHIT, SVV and VNG testing
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
February 28, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
January 11, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
January 14, 2021
Last Update Submitted That Met QC Criteria
January 13, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0226-20-EMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.