Hearing Changes After Surgery

NCT ID: NCT04322747

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Distortion product otoacoustic emissions (DPOAE)

Intervention Type DIAGNOSTIC_TEST

Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.

Interventions

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Distortion product otoacoustic emissions (DPOAE)

Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Electrocochleaography/Electrophysiological testing Tympanometry Audiometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Gateway Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Partha Thirumala, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

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UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Baradaranfar MH, Shahbazian H, Behniafard N, Atighechi S, Dadgarnia MH, Mirvakili A, Mollasadeghi A, Baradaranfar A. The effect of drill-generated noise in the contralateral healthy ear following mastoid surgery: The emphasis on hearing threshold recovery time. Noise Health. 2015 Jul-Aug;17(77):209-15. doi: 10.4103/1463-1741.160691.

Reference Type BACKGROUND
PMID: 26168951 (View on PubMed)

Other Identifiers

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3R41DC017406-01S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19090236

Identifier Type: -

Identifier Source: org_study_id

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