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Clinical Trials/NCT05434637
NCT05434637
Recruiting
N/A

Developing Tools and a Care Path for Somatosensory Tinnitus

VA Office of Research and Development1 site in 1 country72 target enrollmentNovember 1, 2023
ConditionsTinnitus

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tinnitus
Sponsor
VA Office of Research and Development
Enrollment
72
Locations
1
Primary Endpoint
Change in TFI Score
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.

Detailed Description

The purpose of this study is to: (1) develop a screening tool for somatosensory tinnitus and (2) perform a randomized clinical trial comparing different treatment approaches for somatosensory tinnitus. The investigators want to find out if individualized physical therapy, alone or in combination with audiology-based sound therapy, is beneficial for treating somatosensory tinnitus.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
September 30, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Constant, chronic tinnitus (6-months in duration)
  • bothersome tinnitus based on TFI score and self-reported loudness
  • able to modulate tinnitus perception with head, neck, and/or jaw maneuvers

Exclusion Criteria

  • Middle ear pathology
  • not a candidate for physical therapy
  • injury to the temporomandibular area in past 3 months
  • active pathology in the orofacial region

Outcomes

Primary Outcomes

Change in TFI Score

Time Frame: Measured at at baseline; 8 and 12 weeks post-randomization

The TFI is a 25-item questionnaire that evaluates treatment responsiveness (i.e., changes in functional effects of tinnitus over time). Total possible score ranges from 0-to-100 (scores \>25 indicate tinnitus is a significant problem).

Study Sites (1)

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