Hearing Changes After Surgery

August 5, 2022 updated by: Gateway Biotechnology, Inc.

Hearing Changes After Skull Base and Mastoid Surgery

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 surgeries

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (Baradaranfar et al., 2015; Shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. This study aims to to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the non operative ear, during surgical site during skull-based or mastoid surgeries. As part of the study patient will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants scheduled to undergo skull-based and mastoid surgery

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants scheduled to undergo skull-based surgery
Participants scheduled to undergo skull-based or mastoid surgery as part of their standard care will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure in the non operated ear.
Diagnostic test: Distortion product otoacoustic emissions (DPOAE)
Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.
Other Names:
  • Tympanometry
  • Electrocochleaography/Electrophysiological testing
  • Audiometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency
Time Frame: pre-surgery, immediately after surgery, up to one month after surgery
DPOAE measurement using Interacoustics Titan DPOAE440 measurement tool is 5dB or greater from pre-surgery measurement to post-surgery measurement
pre-surgery, immediately after surgery, up to one month after surgery
Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements
Time Frame: pre-surgery, immediately after surgery
DPOAE measurement using interacoustics titan measurement tool has not changed or is less than 5dB from pre-surgery measurement to post-surgery measurement
pre-surgery, immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gateway Biotechnology, Inc.

Collaborators

University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Partha Thirumala, MD, University of Pittsburgh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2021

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

February 28, 2022

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (ACTUAL)

March 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19090236
  • 3R41DC017406-01S1 (NIH)

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.

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