Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013468
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Brief Title:
Early Diagnosis of Steroid-Responsive No-Responsive Hearing Loss
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Early Diagnosis of Steroid-Responsive No-Responsive Hearing Loss
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1Laboratory development of the automated technique for comprehensive tinnitus quantification2Development of a technique to test for tinnitus malingering and 3Evaluation of the automated technique in the clinical environment
This study will be conducted as three concurrent projects designed to develop an efficient clinical technique to quantify tinnitus perception
1Laboratory development of the automated technique for comprehensive tinnitus quantification2Development of a technique to test for tinnitus malingering and 3Evaluation of the automated technique in the clinical environment
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 115000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None