Somatosensory Tinnitus Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03802513|
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : June 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Other: Physical Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Therapeutic Approach for Somatosensory Tinnitus|
|Actual Study Start Date :||December 1, 2019|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||April 1, 2021|
This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.
Other: Physical Therapy
Individualized physiotherapy including exercises to be performed by the Veteran at home.
- Tinnitus Functional Index [ Time Frame: 1 month ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802513
|United States, Oregon|
|VA Portland Health Care System, Portland, OR|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Sarah Theodoroff, PhD||VA Portland Health Care System, Portland, OR|