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Wide Frequency Band Test of Hearing in Veterans

Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02019888
Acronym
CWTBAFV
Enrollment
320
Registered
2013-12-24
Start date
2014-12-01
Completion date
2020-01-31
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesteatoma, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Sensorineural, Otitis Media With Effusion, Otosclerosis, Tympanic Membrane Perforation

Keywords

Ear, Middle, Ear, Inner, Audiometry, Acoustic impedance tests

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.

Interventions

None listed

Sponsors

Father Flanagan's Boys' Home
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Experimental Middle Ear Test: Ambient Wideband AbsorbanceAssessed at the time of enrollment during one 2.5- to 3-hour visit.Ambient Wideband Absorbance is the experimental middle ear test. Results were compared to the Secondary Outcome Measure of Clinical Peak Static Acoustic Admittance. Wideband absorbance was averaged across frequencies from 250 to 8000 Hz on a ratio scale from 0 to 1. In general, higher absorbance is indicative of a better outcome (i.e., better middle ear function).

Secondary

MeasureTime frameDescription
Middle Ear Muscle Reflex TestAssessed at the time of enrollment during one 2.5- to 3-hour visit.This measure is middle ear muscle reflex thresholds in decibel (dB) sound pressure level (SPL) elicited in response to a broadband noise (BBN) activator on the standard clinical system and the experimental wideband (WB) system. The range is from 0 to 95 dB SPL with lower thresholds indicating a better outcome.
Wideband Otoacoustic Emission TestAssessed at the time of enrollment during one 2.5- to 3-hour visit.This measure is the difference between otoacoustic emissions and noise levels in decibels (dB) sound pressure level (SPL) elicited by a chirp averaged across frequencies from 1000 to 8000 Hertz (Hz). The normal range is \ 0 to 20 dB SPL with larger values being better.
Clinical Middle Ear Test: Peak Static Acoustic AdmittanceAssessed at the time of enrollment during one 2.5- to 3-hour visit.Peak Static Acoustic Admittance is the standard clinical middle ear test. Results were compared to the Primary Outcome Measure of Ambient Wideband Absorbance. Peak Static Acoustic Admittance estimated from a 226-Hz tympanogram is measured on a mmho scale from 0.00 mmho to \ 5.0 mmho. The normal range (i.e., normal middle ear function) is 0.3 to 1.7 mmho.

Countries

United States

Participant flow

Participants by arm

ArmCount
Normal Hearing Adults
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
108
Adults With Sensory Neural Hearing Loss
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
83
Adults With Middle Ear Disorders
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
54
Total245

Baseline characteristics

CharacteristicNormal Hearing AdultsAdults With Sensory Neural Hearing LossAdults With Middle Ear DisordersTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants54 Participants36 Participants101 Participants
Age, Categorical
Between 18 and 65 years
97 Participants29 Participants18 Participants144 Participants
Age, Continuous43.42 years
STANDARD_DEVIATION 16.12
66.07 years
STANDARD_DEVIATION 9.93
64.69 years
STANDARD_DEVIATION 12.38
55.78 years
STANDARD_DEVIATION 17.37
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants0 Participants1 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
104 Participants83 Participants53 Participants240 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
9 Participants2 Participants3 Participants14 Participants
Race (NIH/OMB)
More than one race
5 Participants2 Participants0 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
90 Participants79 Participants51 Participants220 Participants
Region of Enrollment
United States
108 Participants83 Participants54 Participants245 Participants
Sex: Female, Male
Female
45 Participants5 Participants11 Participants61 Participants
Sex: Female, Male
Male
63 Participants78 Participants43 Participants184 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1480 / 1130 / 59
other
Total, other adverse events
0 / 1480 / 1130 / 59
serious
Total, serious adverse events
0 / 1480 / 1130 / 59

Outcome results

Primary

Experimental Middle Ear Test: Ambient Wideband Absorbance

Ambient Wideband Absorbance is the experimental middle ear test. Results were compared to the Secondary Outcome Measure of Clinical Peak Static Acoustic Admittance. Wideband absorbance was averaged across frequencies from 250 to 8000 Hz on a ratio scale from 0 to 1. In general, higher absorbance is indicative of a better outcome (i.e., better middle ear function).

Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.

Population: Reflects total number of participants with useable data (reflects where we were in the process of developing the test battery, equipment and software issues, etc.).

ArmMeasureValue (MEAN)Dispersion
Normal Hearing AdultsExperimental Middle Ear Test: Ambient Wideband Absorbance0.39 RatioStandard Deviation 0.15
Adults With Sensory Neural Hearing LossExperimental Middle Ear Test: Ambient Wideband Absorbance0.38 RatioStandard Deviation 0.15
Adults With Middle Ear DisordersExperimental Middle Ear Test: Ambient Wideband Absorbance0.32 RatioStandard Deviation 0.21
Secondary

Clinical Middle Ear Test: Peak Static Acoustic Admittance

Peak Static Acoustic Admittance is the standard clinical middle ear test. Results were compared to the Primary Outcome Measure of Ambient Wideband Absorbance. Peak Static Acoustic Admittance estimated from a 226-Hz tympanogram is measured on a mmho scale from 0.00 mmho to \ 5.0 mmho. The normal range (i.e., normal middle ear function) is 0.3 to 1.7 mmho.

Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.

Population: Reflects total number of participants with useable data (reflects where we were in the process of developing the test battery, equipment and software issues, etc.).

ArmMeasureValue (MEAN)Dispersion
Normal Hearing AdultsClinical Middle Ear Test: Peak Static Acoustic Admittance0.7 admittance in mmhoStandard Deviation 0.24
Adults With Sensory Neural Hearing LossClinical Middle Ear Test: Peak Static Acoustic Admittance0.8 admittance in mmhoStandard Deviation 0.35
Adults With Middle Ear DisordersClinical Middle Ear Test: Peak Static Acoustic Admittance0.81 admittance in mmhoStandard Deviation 0.85
Secondary

Middle Ear Muscle Reflex Test

This measure is middle ear muscle reflex thresholds in decibel (dB) sound pressure level (SPL) elicited in response to a broadband noise (BBN) activator on the standard clinical system and the experimental wideband (WB) system. The range is from 0 to 95 dB SPL with lower thresholds indicating a better outcome.

Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.

Population: This outcome focused on the acoustic reflex part of the test battery which was in development longer than the other outcomes measures. The lower number of participants (in comparison to the number of Baseline Participants) included in this measure reflects the delayed addition of the reflex test to the battery, and missing data due to software or equipment issues.

ArmMeasureGroupValue (MEAN)Dispersion
Normal Hearing AdultsMiddle Ear Muscle Reflex TestClinical System85.45 middle ear muscle reflex in dB SPLStandard Deviation 7.9
Normal Hearing AdultsMiddle Ear Muscle Reflex TestExperimental Wideband System69.54 middle ear muscle reflex in dB SPLStandard Deviation 11.89
Adults With Sensory Neural Hearing LossMiddle Ear Muscle Reflex TestClinical System92.02 middle ear muscle reflex in dB SPLStandard Deviation 3.86
Adults With Sensory Neural Hearing LossMiddle Ear Muscle Reflex TestExperimental Wideband System86.99 middle ear muscle reflex in dB SPLStandard Deviation 7.6
Adults With Middle Ear DisordersMiddle Ear Muscle Reflex TestClinical System94.36 middle ear muscle reflex in dB SPLStandard Deviation 3.05
Adults With Middle Ear DisordersMiddle Ear Muscle Reflex TestExperimental Wideband System93.27 middle ear muscle reflex in dB SPLStandard Deviation 6.68
Secondary

Wideband Otoacoustic Emission Test

This measure is the difference between otoacoustic emissions and noise levels in decibels (dB) sound pressure level (SPL) elicited by a chirp averaged across frequencies from 1000 to 8000 Hertz (Hz). The normal range is \ 0 to 20 dB SPL with larger values being better.

Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.

Population: The lower number of participants (compared to the number of Baseline Participants) included in this measure reflects missing data due to software or equipment issues.

ArmMeasureValue (MEAN)Dispersion
Normal Hearing AdultsWideband Otoacoustic Emission Test10.29 difference level in dB SPLStandard Deviation 2.56
Adults With Sensory Neural Hearing LossWideband Otoacoustic Emission Test4.29 difference level in dB SPLStandard Deviation 1.06
Adults With Middle Ear DisordersWideband Otoacoustic Emission Test3.30 difference level in dB SPLStandard Deviation 3.08

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026