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Tinnitus, commonly referred to as "ringing in the ears", affects 50 million people in the United States and is recognized as a major public health concern. Tinnitus is the most frequent cause of service-connected disability claims among war veterans. Tinnitus remains a subjectively diagnosed entity. There is no standardized objective method of diagnosing tinnitus or describing the functional impact of the condition. Currently, physicians have to rely on patient-based self reports. Without an objective method of diagnosing tinnitus and describing the functional implications, adequate treatment delivery is also hampered since there is no way to objectively stratify patients into severity groups and assess response to treatment. Because tinnitus is known to negatively affect cognition through the ventral attention networks and the prefrontal cortex, measuring cognitive processing speed is a possible way to objectively measure tinnitus. This study builds on previous work the investigators have done that utilized a quick, easily accessible measure of auditory processing speed. That earlier study showed a correlation between that measure and self reported measures of tinnitus severity, and this study attempts determine a more precise estimate of that correlation. It also better validates those results by including a traditional neurocognitive measuring cognitive speed and by controlling for the presence of depression and somatoform disorders.
This was a cross-sectional study designed to investigate the relationship that self-reported tinnitus severity has with cognitive processing speed and psychiatric factors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Speed Test | Brain Speed Test |
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| Measure | Description | Time Frame |
|---|---|---|
| Brain Speed Test | Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations. | Participants completed brain speed test on the same day as enrollment. No follow-up required. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include men and women between the ages of 18-80 years who have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
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| Name | Affiliation | Role |
|---|---|---|
| Jay F Piccirillo | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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Participants were recruited from Washington University's Volunteer for Health office, the audiology division and the otolaryngology faculty clinical practices at Washington University Department of Otolaryngology-Head and Neck Surgery, including the PI's population of tinnitus patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tinnitus | Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tinnitus | Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Speed Test | Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations. | Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated. | Posted | Mean | 95% Confidence Interval | z-score | Participants completed brain speed test on the same day as enrollment. No follow-up required. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tinnitus | Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer. |
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Tinnitus subjects with moderate or greater depression were excluded from the study. This study may not be reflective of the population of bothersome tinnitus patients due to this exclusion
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay F. Piccirillo, Professor | Washington University in St. Louis | 314 362-8641 | piccirilloj@ent.wustl.edu |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
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| 0 |
| 92 |
| 0 |
| 92 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |