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Hearing LossNCT00013468

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

An observational study of Hearing Loss, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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: (1)Laboratory development of the automated technique for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Tinnitus
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteUnited States
Study dates
Aug 2000to Aug 2003
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Hearing impaired

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VAMC, Portland

    Portland, Oregon

Other trials in United States

About this study

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.

Read the 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

Conditions
Hearing Loss
Being tested
Tinnitus
Keywords
Hearing loss, ear, steroids, auditory
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TinnitusProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2001 (estimated)
  2. Study startAug 2000
  3. Study completionAug 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00013468
Sponsor's protocol ID
C2299R
Status last verified
Jan 2001
First submitted
14 Mar 2001
Last updated
21 Jan 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.

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