Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tinnitus is the occurrence of an auditory sensation without the presence of an acoustic stimulus. Approximately, 50 million people in the United States experience chronic tinnitus and 15 million of these people have bothersome tinnitus. Several studies have shown that people who are bothered by their tinnitus have difficulty in concentration and focus. Through imaging modalities we have deranged neural networks responsible for attention. Only 20 percent of patients diagnosed with tinnitus are severely bothered. We seek the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slightly or Non-Bothered Tinnitus Group | Identified by a Tinnitus Handicap Index <36 and a subjective description of their tinnitus as no or slight "bother." A control group has been collected through a different study, i.e. no controls will be recruited in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No treatment for tinnitus will occur in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI | Perform Functional connectivity MRI on participants with non-bothersome tinnitus. By undergoing a functional MRI, we are able to delineate the various networks involved with tinnitus including the default mode, attention, auditory, visual, somatosensory, and cognitive networks. The functional connectivity differences are measured by changes in blood oxygen level changes. | 8 months for complete analysis on all participants |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
19 adults between the ages of 45 and 60 years, age and hearing level-matched to the bothered tinnitus cohort from the on-going research at Washington University. Subjects will be recruited from an institutional tinnitus database, from Washington University Otolaryngology Clinics, as well as the general public through poster advertisement on the Washington University grounds.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andre M Wineland, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University, Center for Clinical Studies | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22722065 | Result | Wineland AM, Burton H, Piccirillo J. Functional connectivity networks in nonbothersome tinnitus. Otolaryngol Head Neck Surg. 2012 Nov;147(5):900-6. doi: 10.1177/0194599812451414. Epub 2012 Jun 21. |
Not provided
Not provided
1 participant was excluded due to claustrophobia from the MRI and another participant withdrew midway through the neurocognitive evaluation due to frustration.
Those with subjective, idiopathic tinnitus were recruited from WU audiology and otolaryngology clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Non-Bothered Tinnitus Group | Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index <30. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Non-Bothered Tinnitus Group | Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index <30. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI | Perform Functional connectivity MRI on participants with non-bothersome tinnitus. By undergoing a functional MRI, we are able to delineate the various networks involved with tinnitus including the default mode, attention, auditory, visual, somatosensory, and cognitive networks. The functional connectivity differences are measured by changes in blood oxygen level changes. | Perform Functional Connectivity MRI on Participants With Non-bothersome Tinnitus. Non-Bothered Tinnitus Group includes participants who answer 'no bother' or 'slight bother' on a global tinnitus bothersome scale and less than 30 on the Tinnitus Handicap Index. | Posted | Number | participants | 8 months for complete analysis on all participants |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Bothered Tinnitus Group | Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index <30. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andre Wineland | Washington University in St. Louis | 314-362-5296 | winelanda@ent.wustl.edu |
Not provided
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |