Hearing Changes After Surgery

Hearing Loss Clinical Trial

Official title:

Hearing Changes After Skull Base and Mastoid Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04322747
• Other study ID #: 19090236
• Secondary ID: 3R41DC017406-01S
• Status: Withdrawn
• Start date: September 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2022
• Source: Gateway Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 28, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Gateway Biotechnology, Inc.	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency	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
Primary	Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements	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