Clinical Trial: Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans

Brief Summary: The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management. Current physiologic tests of auditory function in the standard clinical audiological test battery for Veterans have limited sensitivity in detecting some middle-ear disorders, and do not include a direct test of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of absorbance for improved sensitivity in the assessment of middle-ear function including acoustic reflex testing. The addition of WB tests of cochlear function included in the WB test battery provides an opportunity to improve audiological diagnosis of a range of hearing disorders in Veterans. The automation provided by the WB test battery could provide additional benefits in reducing the duration of the evaluation, leaving more time for evaluation of test findings and counseling. Results from this study may lead to the improvement of audiological care for Veterans with hearing loss.

Detailed Summary:

The goal of this research is to evaluate a comprehensive test battery of new wide-bandwidth, i.e., wideband (WB), acoustical tests of auditory function in the differential diagnosis of middle ear, cochlear and neural pathologies in a population of Veterans. WB tests refer to ear canal tests using sound responses measured from 0.2 kilohertz (kHz) to frequencies as high as 8 kHz, a bandwidth that is critical for speech perception. There will be tests in the battery for middle-ear assessment using power absorption, cochlear assessment using otoacoustic emissions (OAEs) and the acoustic stapedius reflex (ASR) using middle ear power absorption. Results will be compared with a standard single-frequency clinical immittance test battery routinely used in the assessment of auditory function in Veterans. Aim 1 seeks to evaluate the accuracy of the WB test battery in the differential diagnosis of middle-ear pathology and related conductive hearing loss by comparing the sensitivity and specificity of the WB battery to the traditional immittance battery for the following disorders common in Veterans: tympanic membrane perforation, serous otitis media, cholesteatoma, and otosclerosis. Aim 2 seeks to modify a WB ASR test to provide automatic detection of the ASR threshold for comparison with the traditional single-frequency ASR threshold. Aim 3 seeks to validate the use of Transient-evoked otoacoustic emission (TEOAE) and spontaneous otoacoustic emissions (SOAEs)tests in Veterans to assess cochlear status, and evaluate their test performance in classifying ears with normal hearing and sensorineural hearing loss. Finally, Aim 4 seeks to compare the diagnostic accuracy of the full WB test battery with the full single-frequency admittance test battery to detect any type of hearing loss including sensorineural, conductive and mixed. The hypothesis is that the WB test battery is more accurate than the traditional immittance test battery in
Sponsor: VA Office of Research and Development

Current Primary Outcome: Middle ear test [ Time Frame: Assessed at time of enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Middle ear muscle reflex test [ Time Frame: Assessed at time of enrollment ]
  The standard clinical middle ear muscle reflex test assessed with 226 Hz admittance changes, and the experimental wideband middle ear muscle reflex test assessed with wideband admittance and absorbance changes.
• Wideband otoacoustic emission test [ Time Frame: Assessed at time of enrollment ]
  An otoacoustic emission test assessed using a transient wideband stimulus from 1000 to 8000 Hz.

Original Secondary Outcome:

• Middle ear muscle reflex test [ Time Frame: Assessed at time of enrollment ]
  The standard clinical middle ear muscle reflex test assessed with 226 Hz admittance changes, and the experimental wideband middle ear muscle reflex test assessed with wideband admittance and absorbance changes.
• Wideband otoacoustic emission test [ Time Frame: Assessed at time of enrollment ]
  An otoacoustic emission test assessed using a transient widebnad stimlus from 1000 to 8000 Hz.

Information By: VA Office of Research and Development

Dates:
Date Received: December 18, 2013
Date Started: December 1, 2014
Date Completion: January 2019
Last Updated: April 21, 2017
Last Verified: April 2017