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.
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.
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.
- First posted16 Mar 2001 (estimated)
- Study startAug 2000
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- John Fryer, Ph.D., Asst. Director, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development ServiceNancy Rocheleau, Program Analyst, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss
- ClinicalTrials.gov ID
- NCT00013468
- Acronym / sponsor ID
- C2299R
- Conditions
- Hearing Loss
- Keywords
- Hearing loss, ear, steroids, auditory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2000
- Study completion
- Aug 2003 (actual)
- First posted
- 16 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinnitus | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fryer, Ph.D., Asst. Director
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Nancy Rocheleau, Program Analyst
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
1 site in 1 country: see every site and its status.
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.