TinnitusPhase 2NCT00578058
Randomized Trial Of Tinnitus Retraining Therapy
A Phase 2 study testing Counseling and Sound Therapy in people with Tinnitus, run by University of Iowa at 4 sites in United States.
Trial summary
Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Counseling and Sound Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2004to Nov 2009
- Phase
- Phase 2
- 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
Who may be able to join
- Have experienced tinnitus for at least 4 months.
- Have the ability to participate in research.
Who cannot join
- Have a treatable otological disorder.
- Are involved in litigation.
- Have or are suspected of having a serious psychiatric problem.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
University at Buffalo, State University of New York
Buffalo, New York, 14214
University of Iowa
Iowa City, Iowa, 52242
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.
- Conditions
- Tinnitus
- Being tested
- Counseling and Sound Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling and Sound TherapyOther
Tinnitus counseling and sound therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Counseling plus everyday noise type 1 Receives: Other: Counseling and Sound Therapy |
| 2 | Other | Counseling plus static noise type 2 Receives: Other: Counseling and Sound Therapy |
| 3 | Other | Counseling plus static noise type 3 Receives: Other: Counseling and Sound Therapy |
| 4 | Other | Hearing aid and counseling plus everyday noise type 1 Receives: Other: Counseling and Sound Therapy |
| 5 | Other | Hearing aid and counseling plus static noise type 2 Receives: Other: Counseling and Sound Therapy |
| 6 | Other | Hearing aid and counseling plus static noise type 3 Receives: Other: Counseling and Sound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa Tinnitus Handicap Questionnaire
Measured: 18 months
Secondary outcomes (1)
Tinnitus measures
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 posted20 Dec 2007 (estimated)
- Study startJan 2004
- Primary completionNov 2009
- Study completionNov 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.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Investigators
- Richard S Tyler, Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578058
- Sponsor's protocol ID
- R01DC005972
- Other IDs
- R01DC005972
- Status last verified
- Aug 2011
- First submitted
- 18 Dec 2007
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Of Tinnitus Retraining Therapy
- ClinicalTrials.gov ID
- NCT00578058
- Acronym / sponsor ID
- R01DC005972
- Conditions
- Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jan 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Dec 2007 (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.
Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Counseling and Sound TherapyCounseling plus everyday noise type 1 |
| 2 | Other | Other: Counseling and Sound TherapyCounseling plus static noise type 2 |
| 3 | Other | Other: Counseling and Sound TherapyCounseling plus static noise type 3 |
| 4 | Other | Other: Counseling and Sound TherapyHearing aid and counseling plus everyday noise type 1 |
| 5 | Other | Other: Counseling and Sound TherapyHearing aid and counseling plus static noise type 2 |
| 6 | Other | Other: Counseling and Sound TherapyHearing aid and counseling plus static noise type 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have experienced tinnitus for at least 4 months.
- Have the ability to participate in research.
Key exclusion criteria (3 listed)
- Have a treatable otological disorder.
- Are involved in litigation.
- Have or are suspected of having a serious psychiatric problem.
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 |
|---|---|---|
| Counseling and Sound TherapyTinnitus counseling and sound therapy | Other | 1, 2, 3, 4, 5, 6 |
Primary outcome
Iowa Tinnitus Handicap Questionnaire
Time frame: 18 months
1 secondary outcome
Tinnitus measures
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 3 Aug 2011.
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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.
Richard S Tyler, Ph.D. principal investigator
University of Iowa
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Counseling and Sound Therapy in people with Tinnitus, run by University of Iowa at 4 sites 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 2 inclusion and 3 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 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Iowa Tinnitus Handicap Questionnaire (time frame: 18 months). 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 3 Aug 2011.