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Somatosensory Tinnitus RCT

Primary Purpose

Tinnitus

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Therapy

Sound-based Therapy

Combination Therapy

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Individualized Physiotherapy

Sound-based Therapy

Combination Therapy

Arm Description

Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.

Outcomes

Primary Outcome Measures

Change in TFI Score

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05434637

First Posted

June 22, 2022

Last Updated

May 30, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT05434637

Brief Title

Somatosensory Tinnitus RCT

Official Title

Developing Tools and a Care Path for Somatosensory Tinnitus

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 6, 2023 (Anticipated)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

Keywords

Tinnitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Individualized Physiotherapy

Arm Type

Experimental

Arm Description

Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Arm Title

Sound-based Therapy

Arm Type

Active Comparator

Arm Description

Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Arm Title

Combination Therapy

Arm Type

Experimental

Arm Description

Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.

Intervention Type

Other

Intervention Name(s)

Physical Therapy

Other Intervention Name(s)

Individualized Physiotherapy

Intervention Description

Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Intervention Type

Other

Intervention Name(s)

Sound-based Therapy

Other Intervention Name(s)

Audiology Therapy

Intervention Description

Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Intervention Type

Other

Intervention Name(s)

Combination Therapy

Other Intervention Name(s)

Physical Therapy + Audiology Therapy

Intervention Description

Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.

Primary Outcome Measure Information:

Title

Change in TFI Score

Description

Time Frame

Measured at at baseline; 8 and 12 weeks post-randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Theodoroff, PhD

Phone

(503) 220-8262

Ext

51948

Sarah.Theodoroff@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Theodoroff, PhD

Organizational Affiliation

VA Portland Health Care System, Portland, OR

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Portland Health Care System, Portland, OR

City

Portland

State/Province

Oregon

ZIP/Postal Code

97207-2964

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Theodoroff, PhD

Phone

503-220-8262

Ext

51948

Sarah.Theodoroff@va.gov

First Name & Middle Initial & Last Name & Degree

Sarah Theodoroff, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Somatosensory Tinnitus RCT

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