Hearing Loss, SensorineuralCWTBAFVNCT02019888
Wide Frequency Band Test of Hearing in Veterans
An observational study of Hearing Loss, Sensorineural and Hearing Loss, Conductive, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2014to 31 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Draining ear
- Sensory neural hearing loss greater than 55 dB HL
- Cerumen impaction of ear canal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, 37684
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans
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.
Read the 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.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Otosclerosis, Tympanic Membrane Perforation, Otitis Media With Effusion
- Keywords
- Ear, Middle, Ear, Inner, Audiometry, Acoustic impedance tests
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Otosclerosis, Tympanic Membrane Perforation, Otitis Media with Effusion, Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Secondary outcomes (3)
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.
Measured: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
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.
Measured: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
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.
Measured: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start1 Dec 2014
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Father Flanagan's Boys' Home
- Responsible party
- Sponsor
- Investigators
- M. Patrick Feeney, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019888
- Sponsor's protocol ID
- C1268-R
- Acronym
- CWTBAFV
- Status last verified
- Mar 2021
- First submitted
- 18 Dec 2013
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans
- ClinicalTrials.gov ID
- NCT02019888
- Acronym / sponsor ID
- CWTBAFV / C1268-R
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Otosclerosis, Tympanic Membrane Perforation, Otitis Media With Effusion
- Keywords
- Ear, Middle, Ear, Inner, Audiometry, Acoustic impedance tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Father Flanagan's Boys' Home
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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. |
| 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. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- Draining ear
- Sensory neural hearing loss greater than 55 dB HL
- Cerumen impaction of ear canal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experimental Middle Ear Test: Ambient Wideband Absorbance
Time frame: Assessed 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).
3 secondary outcomes
Middle Ear Muscle Reflex Test
Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Wideband Otoacoustic Emission Test
Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Clinical Middle Ear Test: Peak Static Acoustic Admittance
Time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Patrick Feeney, PhD principal investigator
VA Portland Health Care System, Portland, OR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural and Hearing Loss, Conductive, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimental Middle Ear Test: Ambient Wideband Absorbance (time frame: Assessed at the time of enrollment during one 2.5- to 3-hour visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.