TinnitusBSTNCT01222507
Processing Speed as an Objective Measure of Tinnitus
An observational study of Tinnitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overall purpose of this research is to assess whether both the "60 second Brain Game" and the "Brain Speed Test" computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Oct 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tinnitus subjects recruited from speciality clinic and community at large.
Who may be able to join
- Participants must be between the ages of 18 and 80.
- Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6-months duration or longer.
- Participants must be able to read, write and speak using the English language.
- Participants must be able to provide informed consent.
Who cannot join
- Participants with tinnitus related to Workman's Compensation Claim or other litigation-related situations.
- Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia.
- Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear.
- Participants unable to hear the highest volume of the computer-based objective assessments.
- Any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates.
- Any medical condition the PI determines would compromise the safety of the participant or complicate the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The overall purpose of this research is to assess whether both the "60 second Brain Game" and the "Brain Speed Test" computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus.
Read the detailed description
This cross-sectional study aims to assess for deficits in brain processing speed and attention (two cognitive domains whose deficits have been implicated in tinnitus) with the use of the "Brain Speed Test".
- Conditions
- Tinnitus
- Keywords
- tinnitus, cognition, brain processing speed, Brain Fitness Program, Posit Science
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brain Speed Test | 60 subjects who complete 60 Second Brain Game and Brain Speed Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Speed Test
This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.
Measured: Initial study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Posit Science Corporation
- Responsible party
- Principal investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay Piccirillo, MD, Principal investigator, Washington Unieversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222507
- Sponsor's protocol ID
- 10-0829
- Acronym
- BST
- Status last verified
- Sep 2012
- First submitted
- 15 Oct 2010
- Last updated
- 25 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Processing Speed as an Objective Measure of Tinnitus
- ClinicalTrials.gov ID
- NCT01222507
- Acronym / sponsor ID
- BST / 10-0829
- Conditions
- Tinnitus
- Keywords
- tinnitus, cognition, brain processing speed, Brain Fitness Program, Posit Science
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Posit Science Corporation
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 25 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this research is to assess whether both the "60 second Brain Game" and the "Brain Speed Test" computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus.
Detailed description
This cross-sectional study aims to assess for deficits in brain processing speed and attention (two cognitive domains whose deficits have been implicated in tinnitus) with the use of the "Brain Speed Test".
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Speed Test | – | –60 subjects who complete 60 Second Brain Game and Brain Speed Test |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tinnitus subjects recruited from speciality clinic and community at large.
Key inclusion criteria (4 listed)
- Participants must be between the ages of 18 and 80.
- Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6-months duration or longer.
- Participants must be able to read, write and speak using the English language.
- Participants must be able to provide informed consent.
Key exclusion criteria (6 listed)
- Participants with tinnitus related to Workman's Compensation Claim or other litigation-related situations.
- Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia.
- Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear.
- Participants unable to hear the highest volume of the computer-based objective assessments.
- Any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain Speed Test
Time frame: Initial study visit
This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay Piccirillo, MD principal investigator
Washington Unieversity
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 Tinnitus, run by Washington University School of Medicine 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 4 inclusion and 6 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 25 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brain Speed Test (time frame: Initial study visit). 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 25 Oct 2012.