Somatosensory Tinnitus Study

Tinnitus Clinical Trial

Official title:

A New Therapeutic Approach for Somatosensory Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802513
• Other study ID #: C3181-P
• Secondary ID: 1I21RX003181-01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 1, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• Physical Therapy
Individualized physiotherapy including exercises to be performed by the Veteran at home.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 1 month follow-up