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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802513
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tinnitus Other: Physical Therapy Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Therapeutic Approach for Somatosensory Tinnitus
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Single arm
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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veteran
  • chronic tinnitus
  • positive screen for somatosensory tinnitus

Exclusion Criteria:

  • Non-Veteran
  • participation in new (< 1 month) tinnitus management or treatment
  • current participation in tinnitus research involving an intervention

Information from the National Library of Medicine

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


Contacts
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Contact: Sarah Theodoroff, PhD (503) 220-8262 ext 51948 Sarah.Theodoroff@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Theodoroff, PhD    503-220-8262 ext 51948    Sarah.Theodoroff@va.gov   
Principal Investigator: Sarah Theodoroff, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sarah Theodoroff, PhD VA Portland Health Care System, Portland, OR
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03802513    
Other Study ID Numbers: C3181-P
1I21RX003181-01 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
tinnitus
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases