Somatosensory Tinnitus RCT
Developing Tools and a Care Path for Somatosensory Tinnitus
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
September 17, 2025
September 1, 2025
3.7 years
June 22, 2022
September 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Individualized Physiotherapy
EXPERIMENTALIndividuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.
Sound-based Therapy
ACTIVE COMPARATORIndividuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Combination Therapy
EXPERIMENTALIndividuals randomized to this group will receive both individualized physical therapy and sound-based therapy.
Interventions
Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.
Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Middle ear pathology
- not a candidate for physical therapy
- injury to the temporomandibular area in past 3 months
- active pathology in the orofacial region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Theodoroff, PhD
VA Portland Health Care System, Portland, OR
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 28, 2022
Study Start
November 1, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share