The Influence of Covid-19 on the Audio-vestibular System
1 other identifier
interventional
70
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Mar 2021
Typical duration for not_applicable covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJanuary 14, 2021
January 1, 2021
12 months
January 11, 2021
January 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
vestibular function
through study completion, an average of 1 year
Study Arms (2)
Recovered Covid-19 patients
OTHERDiagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
Healthy Control
OTHERDiagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
Interventions
Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
Eligibility Criteria
You may qualify if:
- ages 18-80 performed audiometry testing in the last two years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D/Ph.D.
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 14, 2021
Study Start
March 1, 2021
Primary Completion
February 28, 2022
Study Completion
June 30, 2022
Last Updated
January 14, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share