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Early Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00013468
First Posted: March 16, 2001
Last Update Posted: January 21, 2009
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:
VA Office of Research and Development
  Purpose

Tinnitus is a prevalent issue for veterans who are proportionally more hearing-impaired than the civilian population.

This study will be conducted as three concurrent projects designed to develop an efficient clinical technique to quantify tinnitus perception:

(1)Laboratory development of the automated technique for comprehensive tinnitus quantification;(2)Development of a technique to test for tinnitus "malingering"; and (3)Evaluation of the automated technique in the clinical environment.


Condition Intervention Phase
Hearing Loss Procedure: Tinnitus Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Early Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss

Resource links provided by NLM:


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

Estimated Enrollment: 50
Study Start Date: August 2000
Study Completion Date: August 2003
Detailed Description:

Because of its close association with sensorineural hearing loss, tinnitus is a prevalent issue for veterans who are proportionally more hearing-impaired than the civilian population. The VA system disburses $110 million per year to over 115,000 veterans for their service-connected tinnitus disability, thus it is clearly a problem for veterans and for the VA. Unfortunately, most VAMCs do not have systematic clinical care available for their veterans suffering from tinnitus. The most obvious needs are to develop effective treatment methodologies for veterans, and to standardize a procedure for quantifying the disorder. Each of these concerns is a focus of this laboratory, and the present proposal addresses the latter need as a continuation study to develop reliable techniques to measure tinnitus.

The goal of this proposed study is a fully functional system, documented for response reliability and ready for clinical implementation at VA audiology clinics outside of Portland. To achieve that end goal, the study will be conducted as three concurrent projects: (1) Further laboratory development of the automated technique for comprehensive tinnitus quantification; (2) Development of a technique to test for tinnitus "malingering"; and (3) Evaluation of the automated technique in the clinical environment.

For Project 1, a series of experiments is proposed to reduce the time of testing, and to add new measurement capabilities. Each experiment will involve specification, design, and implementation of program modifications, human subject testing, analysis of results, and further modifications as indicated. Another series of experiments (Project 2) will be conducted to develop a tinnitus malingering exam. With such a test, veterans with true tinnitus would provide reliable responses, while those feigning tinnitus would have difficulty responding reliably. For Project 3, a duplicate measurement system will be installed at the Portland VA Regional Tinnitus Clinic. The automated technique will be used to quantify tinnitus in veteran patients during their tinnitus evaluation. Patients will be invited to return for repeat testing, which will provide reliability data for clinical responses. This project will promote clinical feedback that will be important for final development of the system as a clinical tool.

The three projects outlined above are designed to develop an efficient clinical technique to quantify tinnitus perception. Because the technique is computer automated, its implementation at VA clinics will involve a minimum of training and expenditure. The technique is further expected to impact the medical care of non-VA clinics, and could

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Hearing impaired
  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): NCT00013468


Locations
United States, Oregon
VAMC, Portland
Portland, Oregon, United States
Sponsors and Collaborators
VA Office of Research and Development
Investigators
OverallOfficial: John Fryer, Ph.D., Asst. Director Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
OverallOfficial: Nancy Rocheleau, Program Analyst Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
  More Information

ClinicalTrials.gov Identifier: NCT00013468     History of Changes
Other Study ID Numbers: C2299R
First Submitted: March 14, 2001
First Posted: March 16, 2001
Last Update Posted: January 21, 2009
Last Verified: January 2001

Keywords provided by VA Office of Research and Development:
Hearing loss, ear, steroids, auditory

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