Somatosensory Tinnitus RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Therapy, Sound-based Therapy, Combination Therapy.
- Who it may be relevant to
- Registry conditions: Tinnitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Developing Tools and a Care Path for Somatosensory Tinnitus
Overview
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
- 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. - Other Sound-based Therapy
Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment. - Other Combination Therapy
Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.
Primary outcome measures
- Change in TFI Score [Time frame: Measured at at baseline; 8 and 12 weeks post-randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Portland Health Care System, Portland, OR — Portland
Identifiers
NCT: NCT05434637 · C3924-R