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Early Detection of Noise-Induced Hearing Loss

This study has been withdrawn prior to enrollment.
(We did not enroll any subjects because we realized we needed to establish the technique more definitively before proceeding to human testing.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022710
First Posted: December 1, 2009
Last Update Posted: December 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition
Hearing Loss, Sensorineural

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Early Detection of Noise-Induced Hearing Loss

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • DP-gram with interference tone 1/3 octave above f2 [ Time Frame: At the end of the testing session ]

Biospecimen Retention:   None Retained
No biospecimens will be collected for this study

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Veterans with sensorineural hearing loss

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Veterans reporting to the VA Loma Linda Healthcare System identified with sensorineural hearing loss
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022710


Locations
United States, California
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Glen K Martin, PhD VA Loma Linda Healthcare System, Loma Linda, CA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022710     History of Changes
Other Study ID Numbers: C7107-R
00860 ( Other Grant/Funding Number: Department of Veterans Affairs )
First Submitted: November 25, 2009
First Posted: December 1, 2009
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by VA Office of Research and Development:
hearing loss
otoacoustic emissions

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms