Hearing Changes After Surgery

Withdrawn

• Conditions: Hearing Loss
• Interventions: Diagnostic Test: Distortion product otoacoustic emissions (DPOAE)

• Registration Number: NCT04322747
• Lead Sponsor: Gateway Biotechnology, Inc.

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 surgeries

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 Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Study Start: 2021-09-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants scheduled to undergo skull-based surgery	Distortion product otoacoustic emissions (DPOAE)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency	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
Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements	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

Trial Locations

Locations (1)

UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States