Clinical trial NCT02019888: Wide Frequency Band Test of Hearing in Veterans
Official title: Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Otosclerosis
Tympanic Membrane Perforation
Otitis Media With Effusion
Cholesteatoma
Keywords: Ear, Middle
Ear, Inner
Audiometry
Acoustic impedance tests
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Father Flanagan's Boys' Home
First posted: 2013-12-24
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans will be recruited for this study who have had a hearing evaluation from the VA Audiology Service at the Portland VA Medical Center and the H. Quillen VA Medical Center. We may also recruit from approved subject registries at each study site, and from those who respond to approved fliers posted at the each site.

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 description: 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 identifying ears with normal auditory status and ears with a range of risks for auditory pathology.

Methods:

Subjects- Human subjects will be recruited for this study who have had a hearing evaluation from the VA Audiology Service at the Portland VA Medical Center and the H. Quillen VA Medical Center. These subjects will respond to flyers or be contacted from an IRB-approved human subject volunteer registry. Additional details regarding recruitment and selection criteria may be found in the next sections of the protocol. The investigators will recruit approximately equal numbers of subjects, with a total of 640. Data will be acquired at the two sites from a total of 190 adult subjects with normal hearing and 180 adult subjects with sensorineural hearing loss. These subjects will be recruited from three age groups: 20-39 years, 40-59 years and 60-79 years for age comparisons of normative middle-ear data. Data will also be acquired at both sites from 250 adult subjects with middle-ear disorders and/or conductive hearing loss from ages 20-89 years. Of this latter group, the investigators plan to enroll 50 subjects with tympanic membrane perforation, 50 subjects with serous otitis media, 50 subjects with cholesteatoma, 50 subjects with otosclerosis, and 50 subjects with unspecified middle-ear disorders. The investigators expect that approximately 20 subjects (from all groups, normal hearing, sensorineural hearing loss, and middle-ear disorders) will be lost as screen failures or will drop from the study, and thus, the investigators will recruit an additional 20 subjects to replace these. This brings the total planned number of subjects recruited for study to 640.

Testing- All subjects will receive the same clinical and WB test battery. Each subject will be tested in one laboratory visit. Subjects will be enrolled in this study that upon otoscopic inspection of their ear canals, have no active drainage from the ears, and have ear canals free of cerumen (wax) impaction, bilaterally. Subjects who are found to have draining ears or cerumen impaction will be referred for treatment. These individuals may be enrolled in the study following successful treatment for their conditions. All subjects will have a standard pure-tone air- and bone-conduction audiogram while comfortably seated in a sound-treated booth. Standard insert earphones and a bone-conduction vibrator will be used to present the sound stimuli. Next, speech audiometry will be completed and the speech reception thresholds, uncomfortable loudness test for speech, and speech recognition scores will be obtained. Then the subjects will have a standard immittance test battery consisting of a tympanogram and acoustic reflex threshold testing. Stimuli will not exceed a level of 100 decibels hearing level (dB HL). Finally, the wideband test battery will be performed with adults seated comfortably in a sound-treated booth. A small probe with a soft rubber tip will be inserted in the subject's ear canal, and the subject will be asked to remain quiet while sounds are presented to an ear via sound sources within the probe. Responses will be measured using a miniature microphone within the probe. The tests in the wideband battery are similar to the clinical admittance battery and include ambient absorbance, absorbance tympanometry and acoustic reflex threshold. The otoacoustic emission testing is a separate measurement of inner ear function typically conducted in the clinic using different equipment.

Eligibility criteria: Inclusion Criteria:

Adults with normal hearing

* Veteran status
* Age between 20 and 79 years
* All puretone thresholds at 25 dB HL or lower

Adults with sensory neural hearing loss

* Veteran status
* Age between 20 and 79 years
* Average hearing thresholds between 26 and 55 dB HL

Adults with middle ear disorders

* Veteran status
* Adult between 20 and 89 years
* Diagnosis of middle ear disorder

Exclusion Criteria:

* Draining ear
* Sensory neural hearing loss greater than 55 dB HL
* Cerumen impaction of ear canal

Primary outcomes:
measure: Experimental Middle Ear Test: Ambient Wideband Absorbance
timeFrame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Secondary outcomes:
measure: Middle Ear Muscle Reflex Test
timeFrame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
measure: Wideband Otoacoustic Emission Test
timeFrame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
measure: Clinical Middle Ear Test: Peak Static Acoustic Admittance
timeFrame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Mountain Home
country: United States
facility: Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
state: Tennessee
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: M. Patrick Feeney, PhD
role: PRINCIPAL_INVESTIGATOR
References: