Tinnitus
Conditions
Keywords
Tinnitus
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.
Interventions
OTHERPhysical 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.
OTHERSound-based Therapy
Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
OTHERCombination Therapy
Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Constant, chronic tinnitus (6-months in duration) * Bothersome tinnitus based on Tinnitus Functional Index (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Functional Index (TFI) Score | Measured at at baseline; 8 and 12 weeks post-randomization | The Tinnitus Functional Index (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). |
Countries
United States
Contacts
CONTACTSarah Theodoroff, PhD
PRINCIPAL_INVESTIGATORSarah Theodoroff, PhD
VA Portland Health Care System, Portland, OR
Outcome results
None listed