Somatosensory Tinnitus RCT

Tinnitus Clinical Trial

Official title:

Developing Tools and a Care Path for Somatosensory Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434637
• Other study ID #: C3924-R
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Sarah Theodoroff, PhD
• Phone: (503) 220-8262
• Email: Sarah.Theodoroff[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• Sound-based Therapy
Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
• Combination Therapy
Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.

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