TinnitusPhase 1NCT00124800
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus
A Phase 1 study testing Tinnitus retraining therapy and Sound therapy in people with Tinnitus, run by Tinnitus Research Consortium at 1 site in United States.
Trial summary
The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Tinnitus retraining therapy and Sound therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jun 2009
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic non-pulsatile tinnitus
Who cannot join
- Hyperacusis
- Subjective hearing loss
- Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
- Evidence of significant depression or suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
About this study
The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.
Read the detailed description
The specific aims of the study are to:
- Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
- Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
- Determine the therapeutic time course of improvement in tinnitus.
- Determine the long-term improvement in tinnitus derived from TRT.
- Conditions
- Tinnitus
- Being tested
- Tinnitus retraining therapy, Sound therapy
- Keywords
- tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus retraining therapyBehavioural
Sound therapy and counseling
Sound therapyDevice
sound therapy and counselling
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective measure of tinnitus loudness using psychoacoustic matching task
Measured: 18 months
Change in subjective handicap rating of tinnitus using a standardized questionnaire
Measured: 18 months
Secondary outcomes (1)
Change in subjective ratings of tinnitus loudness, annoyance and awareness
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tinnitus Research Consortium
- Sponsor type
- University, hospital or other
- Investigators
- Carol A Bauer, MD, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124800
- Sponsor's protocol ID
- 05-014
- Status last verified
- Sep 2009
- First submitted
- 27 Jul 2005
- Last updated
- 24 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT00124800
- Acronym / sponsor ID
- 05-014
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tinnitus Research ConsortiumUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Jul 2005 (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.
The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.
Detailed description
The specific aims of the study are to:
- Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
- Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
- Determine the therapeutic time course of improvement in tinnitus.
- Determine the long-term improvement in tinnitus derived from TRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic non-pulsatile tinnitus
Key exclusion criteria (4 listed)
- Hyperacusis
- Subjective hearing loss
- Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
- Evidence of significant depression or suicidal ideation
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 retraining therapySound therapy and counseling | Behavioural | – |
| Sound therapysound therapy and counselling | Device | – |
Primary outcome
Change in objective measure of tinnitus loudness using psychoacoustic matching task
Time frame: 18 months
Change in subjective handicap rating of tinnitus using a standardized questionnaire
Time frame: 18 months
1 secondary outcome
Change in subjective ratings of tinnitus loudness, annoyance and awareness
Time frame: 18 months
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 24 Sep 2009.
- Related InfoLink provided by the sponsor.
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A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
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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.
Carol A Bauer, MD principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tinnitus retraining therapy and Sound therapy in people with Tinnitus, run by Tinnitus Research Consortium 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?
The sponsor lists 1 inclusion and 4 exclusion criteria. 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 24 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Change in objective measure of tinnitus loudness using psychoacoustic matching task (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Sep 2009.