Clinical trial NCT04322747: Hearing Changes After Surgery
Official title: Hearing Changes After Skull Base and Mastoid Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hearing Loss
Keywords: Hearing changes
Non-surgical ear
Hearing loss
Vibration exposure
Skull-based surgery
Un-operated ear
Lead sponsor: Gateway Biotechnology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Pittsburgh
First posted: 2020-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants scheduled to undergo skull-based and mastoid surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency
timeFrame: pre-surgery, immediately after surgery, up to one month after surgery
measure: Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements
timeFrame: pre-surgery, immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Partha Thirumala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.