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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

  • United States
    • California
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System, Loma Linda, CA

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1
Veterans with sensorineural hearing loss

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
DP-gram with interference tone 1/3 octave above f2
Time Frame: At the end of the testing session
At the end of the testing session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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