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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX003181-01 | U.S. NIH Grant/Contract | View source |
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Somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The Cleveland Clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.
Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a VA population.
Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in Veterans with tinnitus).
Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during Phase 1A.
Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Physiotherapy | Other | This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Other | Individualized physiotherapy including exercises to be performed by the Veteran at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Functional Index | The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem). | Baseline and 1 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Theodoroff, PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individualized Physiotherapy | This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy. Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individualized Physiotherapy | This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy. Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home. |
| 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 | Tinnitus Functional Index | The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 month follow-up |
|
|
The time frame for each participant's involvement in the study, and hence being monitored for adverse events, ranged from approximately 1 to 3 months.
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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 | Individualized Physiotherapy | This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy. Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home. |
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In-person research-related activities were limited due to COVID-19.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | VA RR&D National Center for Rehabilitative Auditory Research | 503-220-8262 | sarah.theodoroff@va.gov |
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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 | Dec 10, 2020 | Feb 23, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2020 | May 28, 2021 | 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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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |