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Clinical Trials/NCT03802513
NCT03802513
Completed
N/A

A New Therapeutic Approach for Somatosensory Tinnitus

VA Office of Research and Development1 site in 1 country10 target enrollmentDecember 1, 2019
ConditionsTinnitus

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tinnitus
Sponsor
VA Office of Research and Development
Enrollment
10
Locations
1
Primary Endpoint
Tinnitus Functional Index
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
April 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Tinnitus Functional Index

Time Frame: Baseline and 1 month follow-up

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).

Study Sites (1)

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