Status:
WITHDRAWN
Hearing Changes After Surgery
Lead Sponsor:
Gateway Biotechnology, Inc.
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Pittsburgh
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surge...
Detailed Description
High-speed drills that are capable of producing elevated levels are used during skull based surgeries (Hilmi et al., 2011; Yu et al., 2014). Recently, it has been shown that surgical drilling may have...
Eligibility Criteria
Inclusion
- participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear
- participants have normal or near-normal hearing thresholds in the un-operated ear
Exclusion
- participants have hearing loss (PTA \> 40 dB HL) in pure tone audiometry testing before surgery in the un-operated ear
- participants have medical conditions after the surgery which prevents having hearing tests
- participants have abnormal tympanometric results
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04322747
Start Date
September 1 2021
End Date
February 28 2022
Last Update
August 9 2022
Active Locations (1)
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1
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213