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Somatosensory Tinnitus Study

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Individualized Physiotherapy

Arm Description

This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
May 16, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03802513
Brief Title
Somatosensory Tinnitus Study
Official Title
A New Therapeutic Approach for Somatosensory Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized Physiotherapy
Arm Type
Other
Arm Description
This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Individualized physiotherapy including exercises to be performed by the Veteran at home.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index
Description
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).
Time Frame
Baseline and 1 month follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Theodoroff, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Somatosensory Tinnitus Study

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