Somatosensory Tinnitus RCT

September 11, 2025 updated by: VA Office of Research and Development

Developing Tools and a Care Path for Somatosensory Tinnitus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • Recruiting
        • VA Portland Health Care System, Portland, OR
        • Contact:
        • Principal Investigator:
          • Sarah Theodoroff, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized Physiotherapy
Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.
Other: Physical Therapy
Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.
Other Names:
  • Individualized Physiotherapy
Active Comparator: Sound-based Therapy
Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Other: Sound-based Therapy
Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Other Names:
  • Audiology Therapy
Experimental: Combination Therapy
Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.
Other: Combination Therapy
Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.
Other Names:
  • Physical Therapy + Audiology Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured at at baseline; 8 and 12 weeks post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Sarah Theodoroff, PhD, VA Portland Health Care System, Portland, OR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3924-R

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on Physical Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe