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| Name | Class |
|---|---|
| Wallace H Coulter Center for Translational Research | OTHER |
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The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.
This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.
The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham 1st (Auditory only) then Active (Bimodal) | Other | To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. |
|
| Active (Bimodal) then Sham (Auditory only) | Other | During active treatment, the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Treatment: unimodal auditory stimulation | Device | All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study. | Four weeks on treatment (or sham) |
| Change in Tinnitus Loudness as Assessed by TinnTester | Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods. | 4 weeks on treatment (or sham) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Shore, Ph.D | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Kresge Hearing Research Institute | Ann Arbor | Michigan | 48109 | United States |
14 participants consented to the study, but were screened out of allocation to either arm for excess hearing loss, lack of somatosensory modulation, or unwillingness to participate (largely due to time committments/availability).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham 1st (Auditory Only) Then Active (Bimodal) | To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on s |
| FG001 | Active (Bimodal) Then Sham (Auditory Only) | During active treatment, the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on s |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data are included only for those participants for whom outcome measure data was completed (N=20). One subject was consented and began the study, but withdrew after week one.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active 1st (Bimodal) Then Sham (Auditory Only) | During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum. |
| 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 | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study. | First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment). | Posted | Mean | Standard Deviation | units on a scale | Four weeks on treatment (or sham) |
|
12 weeks of treatment or sham
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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 | Active Before Sham |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Shore, Professor of Otolaryngology | University of Michigan | 734 647-2116 | sushore@umich.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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| Active Treatment: Bimodal auditory-somatosensory stimulation | Device | Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone. |
|
| BG001 | Sham 1st (Auditory Only) Then Active (Bimodal) | To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tinnitus Functional Index (TFI) | Baseline measure of TFI score. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact. This measure will be performed at baseline, as well as time points following active, washout, or sham periods. | Mean | Standard Deviation | units on a scale |
|
| Tinnitus Loudness | Tinnitus matching loudness score at baseline assessment. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels/dB) they perceive their tinnitus to be (TinnTester). This measure will be performed at baseline, as well as time points following active, washout, or sham periods. | Mean | Standard Deviation | dB |
|
| OG001 | Washout After Active |
| OG002 | Sham After Active |
| OG003 | Sham Before Active |
| OG004 | Washout After Sham |
| OG005 | Active After Sham |
|
|
|
| Primary | Change in Tinnitus Loudness as Assessed by TinnTester | Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods. | First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment). | Posted | Mean | Standard Deviation | dB | 4 weeks on treatment (or sham) |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Washout After Active | 0 | 10 | 0 | 10 |
| EG002 | Sham After Active | 0 | 10 | 0 | 10 |
| EG003 | Sham Before Active | 0 | 11 | 0 | 11 |
| EG004 | Washout After Sham | 0 | 10 | 0 | 10 |
| EG005 | Active After Sham | 0 | 10 | 0 | 10 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |