Somatosensory Tinnitus Study
A New Therapeutic Approach for Somatosensory Tinnitus
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
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
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
May 17, 2022
CompletedMay 17, 2022
May 1, 2022
1.3 years
January 10, 2019
February 23, 2022
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Individualized Physiotherapy
OTHERThis study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.
Interventions
Individualized physiotherapy including exercises to be performed by the Veteran at home.
Eligibility Criteria
You may qualify if:
- Veteran
- chronic tinnitus
- positive screen for somatosensory tinnitus
You may not qualify if:
- Non-Veteran
- participation in new (\< 1 month) tinnitus management or treatment
- current participation in tinnitus research involving an intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In-person research-related activities were limited due to COVID-19.
Results Point of Contact
- Title
- Principal Investigator
- Organization
- VA RR&D National Center for Rehabilitative Auditory Research
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Theodoroff, PhD
VA Portland Health Care System, Portland, OR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 14, 2019
Study Start
December 1, 2019
Primary Completion
March 31, 2021
Study Completion
April 1, 2021
Last Updated
May 17, 2022
Results First Posted
May 17, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share