- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01022710
Early Detection of Noise-Induced Hearing Loss
December 22, 2015 updated by: VA Office of Research and Development
This study measures sounds produced by the sensory receptors of the inner ear called hair cells.
These sounds are called otoacoustic emissions and one special case the investigators are studying are called distortion product otoacoustic emissions (DPOAEs) produced by presenting two tones to the ear.
If the ear is damaged by noise exposure DPOAEs are reduced.
In this study the investigators are attempting to improve the DPOAE test by adding a third tone to make the test more frequency specific.
Whether the third tone helps will be determined by comparing DPOAEs collected with and without the third tone to clinical audiograms.
If the addition of the third tone helps then the investigators expect DPOAEs tracked as a function of frequency (DP-grams) will more closely match the clinical audiograms.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
The overall goal of the proposed research is to identify features of distortion product otoacoustic emissions (DPOAEs) that will eventually improve clinical methods for the early detection of noise-induced hearing loss (NIHL), which is a major sensory disability suffered by military Veterans, in particular.
Toward this end, a special-purpose DPOAE measure the investigators call an augmented will be obtained.
These DP-grams will test the notion that subtle post-noise changes in the DPOAE response space can be more sensitively identified when the f2 and basal source DPOAEs are isolated by the use of an interference tone (IT) and vector subtraction methods than by the commonly employed standard DP-gram procedures.
The term 'augmented' maps or DP-grams was coined to describe these frequency functions when obtained with the IT present in that, under this condition, the basal source that 'fills in' or 'masks' the damage pattern is removed.
The discovery of the contaminating basal source promises to modify the hearing field's current knowledge concerning the fundamental processes underlying DPOAE generation, and may also lead to the development of DPOAE tests that more sensitively identify the earliest stages of NIHL.
Such tests may also be useful in Veterans, who are clinic patients and often have significant preexisting hearing losses in that higher-level primary tones can be used to increase the signal-to-noise ratio (SNR) while maintaining their sensitivity and frequency specificity.
The investigators will test the ability of augmented DP-grams elicited by higher-level primary tones to uncover damaged regions in Veterans with NIHL.
The notion examined here is that high-level primary tones will be more useful under conditions of preexisting hearing loss than conventional low-level primaries using the optimized augmented DP-gram by removing basal sources that come into play to obscure damaged cochlear regions as primary-tone levels are increased.
Together, the combined experiments will provide a more complete understanding of the generation of DPOAEs, which will permit the creation of a useful clinical test for diagnosing and monitoring the development of NIHL.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92357
- VA Loma Linda Healthcare System, Loma Linda, CA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Veterans reporting to the VA Loma Linda Healthcare System identified with sensorineural hearing loss
Description
Inclusion Criteria:
- Veterans 18-65 years old
Exclusion Criteria:
- Individuals with no measurable distortion-product otoacoustic emissions (DPOAEs) since the goal of the study is to relate DPOAEs to hearing function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Veterans with sensorineural hearing loss
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DP-gram with interference tone 1/3 octave above f2
Time Frame: At the end of the testing session
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At the end of the testing session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Glen K Martin, PhD, VA Loma Linda Healthcare System, Loma Linda, CA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martin GK, Stagner BB, Fahey PF, Lonsbury-Martin BL. Steep and shallow phase gradient distortion product otoacoustic emissions arising basal to the primary tones. J Acoust Soc Am. 2009 Mar;125(3):EL85-92. doi: 10.1121/1.3073734.
- Martin GK, Stagner BB, Lonsbury-Martin BL. Evidence for basal distortion-product otoacoustic emission components. J Acoust Soc Am. 2010 May;127(5):2955-72. doi: 10.1121/1.3353121.
- Martin GK, Stagner BB, Chung YS, Lonsbury-Martin BL. Characterizing distortion-product otoacoustic emission components across four species. J Acoust Soc Am. 2011 May;129(5):3090-103. doi: 10.1121/1.3560123.
- Martin GK, Stagner BB, Lonsbury-Martin BL. Time-domain demonstration of distributed distortion-product otoacoustic emission components. J Acoust Soc Am. 2013 Jul;134(1):342-55. doi: 10.1121/1.4809676.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
June 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
November 30, 2009
First Posted (Estimate)
December 1, 2009
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C7107-R
- 00860 (Other Grant/Funding Number: Department of Veterans Affairs)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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