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Early Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss
This study has been completed.
Study NCT00013468   Information provided by Department of Veterans Affairs
First Received: March 14, 2001   Last Updated: January 20, 2009   History of Changes

March 14, 2001
January 20, 2009
August 2000
 
 
 
Complete list of historical versions of study NCT00013468 on ClinicalTrials.gov Archive Site
 
 
 
Early Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss
Early Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss

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.

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

Phase II
Observational
Prospective
Hearing Loss
Procedure: Tinnitus
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
August 2003
 

Hearing impaired

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013468
 
C2299R
Department of Veterans Affairs
 
Investigator: John Fryer, Ph.D., Asst. Director Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Nancy Rocheleau, Program Analyst Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Department of Veterans Affairs
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP