Hearing Changes After Surgery

NCT04322747 | Withdrawn

• 2 other identifiers: 190902363R41DC017406-01S1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Hearing Loss

Keywords

Hearing changes; Non-surgical ear; Hearing loss; Vibration exposure; Skull-based surgery; Un-operated ear

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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)

Interventions

Distortion product otoacoustic emissions (DPOAE) DIAGNOSTIC_TEST

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

Also known as: Electrocochleaography/Electrophysiological testing, Tympanometry, Audiometry

Participants scheduled to undergo skull-based surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants scheduled to undergo skull-based and mastoid surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gateway Biotechnology, Inc.: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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.

  PMID: 26168951 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Acoustic Impedance Tests; Audiometry

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Partha Thirumala, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 26, 2020
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 28, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

US (1)