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| ID | Type | Description | Link |
|---|---|---|---|
| 1RF1MH114244 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss in the tinnitus frequencies. Subjects must also have the ability to alter the loudness or pitch of the ringing in their ears by performing a head, neck, face, or upper body movement. Subjects will be given both the treatment and sham arms (the study will randomly assign which arm is administered first) and will have a washout period of 6 weeks after each arm. The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham then Active | Other | Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation 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 then Sham | Other | Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation Subjects receive both an active treatment and a sham 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burst-SCS/sham SCS | Device | The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone. Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objective Tinnitus Loudness | Change in Tinnitus by the TinnTester software. Participants are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). These will be collected weekly during each treatment arm and washout. Absolute differences are averaged relative to baseline to determine loudness change. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. | Up to 24 weeks |
| Change in Tinnitus Functional Index (TFI) | TFI is a clinical questionnaire that assesses tinnitus impact on a participant'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. These will be collected weekly during each treatment arm and washout. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and PSM 36 weeks, and the same pattern for the Sham First group. Values presented are all shown as change from baseline. | Up to 36 weeks |
| Tinnitus Handicap Inventory (THI) | A 25 item questionnaire which assesses subjective impacts of tinnitus related to quality of life on a 100 point numeric scale. Scores 17 points or higher are considered bothersome tinnitus. The higher scores reflecting greater self-perceived tinnitus handicap. These will be collected weekly during each treatment arm and washout. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tinnitus Bandwidth/Spectrum (TinnTester Interactive Software) | Participants are guided through a self-directed computerized assessment software that estimates how similar their tinnitus is to a set of select sounds rated on a 0 - 100 scale where 0 is not similar & 100 is identical. Treatment will relate outcomes to tinnitus bandwidth by these measurements and determine whether the treatment alters bandwidth. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline. |
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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 |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37266943 | Derived | Jones GR, Martel DT, Riffle TL, Errickson J, Souter JR, Basura GJ, Stucken E, Schvartz-Leyzac KC, Shore SE. Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2315914. doi: 10.1001/jamanetworkopen.2023.15914. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Then Sham | Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation Subjects receive both an active treatment and a sham 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 SCS/Burst-SCS: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion 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. For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks. |
| FG001 | Sham Then Active | Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation 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. Burst-SCS/sham SCS: The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone. Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Then Sham | Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation Subjects receive both an active treatment and a sham 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 SCS/Burst-SCS: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion 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. For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Objective Tinnitus Loudness | Change in Tinnitus by the TinnTester software. Participants are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). These will be collected weekly during each treatment arm and washout. Absolute differences are averaged relative to baseline to determine loudness change. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. | Because of the crossover nature of this trial, and to determine whether spillover effects were present, participants are represented multiple times for each segment of the trial in which they participated. | Posted | Mean | Standard Error | decibels sensation level (dB SL) | Up to 24 weeks |
|
From screening until end of Post-Study Monitoring (PSM) period up to 36 weeks
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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 | Post-Enrollment Through Baseline Measures, Pre-use | all participants prior to use of either device (active or sham) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| medical infections | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Shore | University of Michigan | 734-647-2116 | sushore@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2022 | Aug 4, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2022 | Aug 2, 2022 | ICF_000.pdf |
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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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|
|
| Sham SCS/Burst-SCS | Device | Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion 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. For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks. |
|
|
| Up to 24 weeks |
| Up to 24 weeks |
| Changes in Minimum Masking Level (MML) | Determine if the MML for a high-pass 2kHz broadband noise is change in the active treatment arm. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline. | Up to 24 weeks |
| Tinnitus Hearing Survey | This is a 10-question survey with a scale from 0 to 4 to determine if active treatment has an effect or interaction with perceived handicap due to hearing loss and sound level tolerance. Categories are comprised of tinnitus, hearing, and sound tolerance. An answer of 0 is no/not a problem, and an answer of 4 is yes/a very big problem. The range for the total score is 0 - 40 with lower numbers meaning fewer hearing problems and higher numbers meaning more tinnitus, or hearing or sound tolerance problems. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. | Up to 24 weeks |
| BG001 | Sham Then Active | Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation 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. Burst-SCS/sham SCS: The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone. Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Objective Tinnitus Loudness | Participants are guided through a self-directed computerized assessment software (TinnTester) that estimates how loud (in decibels) they perceive their tinnitus to be. | Mean | Standard Deviation | decibels |
|
| Tinnitus Functional Index (TFI) | 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. | Mean | Standard Deviation | score on a scale |
|
| Tinnitus Handicap Inventory (THI) | A 25-item questionnaire which assesses subjective impacts of tinnitus related to quality of life on a 100-point numeric scale. Scores 17 points or higher are considered bothersome tinnitus. The higher scores reflecting greater self-perceived tinnitus handicap. | Mean | Standard Deviation | score on a scale |
|
| Minimum Masking Level (MML) | Mean | Standard Deviation | dB (sensation level) |
|
| Tinnitus Hearing Survey | 10-question survey with a scale from 0 to 4 to determine if active treatment has an effect or interaction with perceived handicap due to hearing loss and sound level tolerance. Categories are comprised of tinnitus, hearing, and sound tolerance. An answer of 0 is no/not a problem, and an answer of 4 is yes/a very big problem. | Mean | Standard Deviation | score on a scale |
|
| Active First |
Participants who were assigned to the bimodal auditory-somatosensory stimulation (intervention) initially following randomization and completed treatment. |
| OG001 | Active-First Washout | Participants who received the intervention initially following randomization and completed the first washout period. |
| OG002 | Active-First Then Sham | Participants who initially received the intervention following randomization and completed treatment with the sham bimodal auditory-somatosensory stimulation (sham) following the first washout period. |
| OG003 | Active-First-Then-Sham Washout | Participants who completed the second washout after initially receiving the intervention following randomization and then received the sham following the first washout period. |
| OG004 | Sham First | Participants who were assigned to the sham bimodal auditory-somatosensory stimulation (sham) initially following randomization and completed treatment. |
| OG005 | Sham-First Washout | Participants who received the sham initially following randomization and completed the first washout period. |
| OG006 | Sham-First Then Active | Participants who initially received the sham following randomization and completed treatment with the bimodal auditory-somatosensory stimulation (intervention) following the first washout period. |
| OG007 | Sham-First-Then-Active Washout | Participants who completed the second washout after initially receiving the sham following randomization and then received the intervention following the first washout period. |
|
|
| Primary | Change in Tinnitus Functional Index (TFI) | TFI is a clinical questionnaire that assesses tinnitus impact on a participant'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. These will be collected weekly during each treatment arm and washout. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and PSM 36 weeks, and the same pattern for the Sham First group. Values presented are all shown as change from baseline. | Posted | Mean | Standard Error | Points on a Scale | Up to 36 weeks |
|
|
|
| Primary | Tinnitus Handicap Inventory (THI) | A 25 item questionnaire which assesses subjective impacts of tinnitus related to quality of life on a 100 point numeric scale. Scores 17 points or higher are considered bothersome tinnitus. The higher scores reflecting greater self-perceived tinnitus handicap. These will be collected weekly during each treatment arm and washout. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline. | Posted | Mean | Standard Error | Points on a Scale | Up to 24 weeks |
|
|
|
| Secondary | Change in Tinnitus Bandwidth/Spectrum (TinnTester Interactive Software) | Participants are guided through a self-directed computerized assessment software that estimates how similar their tinnitus is to a set of select sounds rated on a 0 - 100 scale where 0 is not similar & 100 is identical. Treatment will relate outcomes to tinnitus bandwidth by these measurements and determine whether the treatment alters bandwidth. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline. | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| Secondary | Changes in Minimum Masking Level (MML) | Determine if the MML for a high-pass 2kHz broadband noise is change in the active treatment arm. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline. | Posted | Mean | Standard Deviation | dB (sensation level) | Up to 24 weeks |
|
|
|
| Secondary | Tinnitus Hearing Survey | This is a 10-question survey with a scale from 0 to 4 to determine if active treatment has an effect or interaction with perceived handicap due to hearing loss and sound level tolerance. Categories are comprised of tinnitus, hearing, and sound tolerance. An answer of 0 is no/not a problem, and an answer of 4 is yes/a very big problem. The range for the total score is 0 - 40 with lower numbers meaning fewer hearing problems and higher numbers meaning more tinnitus, or hearing or sound tolerance problems. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. | Posted | Mean | Standard Deviation | score on a scale | Up to 24 weeks |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 3 |
| 99 |
| EG001 | Active | All participants while using active device | 0 | 86 | 0 | 86 | 19 | 86 |
| EG002 | Active-Washout Period | All participants in the washout period after active device | 0 | 80 | 0 | 80 | 9 | 80 |
| EG003 | Sham | All participants while on sham device | 0 | 89 | 0 | 89 | 16 | 89 |
| EG004 | Sham-Washout Period | ll participants in the washout period following sham device | 0 | 82 | 0 | 82 | 12 | 82 |
| EG005 | Post-Study Monitoring (PSM) | all participants in post-study monitoring | 0 | 76 | 0 | 76 | 1 | 76 |
| ent - head | Ear and labyrinth disorders | Systematic Assessment |
|
| worsened tinnitus | Nervous system disorders | Systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |