Somatosensory Tinnitus Study

A New Therapeutic Approach for Somatosensory Tinnitus

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Other: Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Individualized Physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: tinnitus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: C3181-P; 1I21RX003181-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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