Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Minnesota
- Locations
- 2
- Primary Endpoint
- Change in Tinnitus Rating (0-10, 10 being worst)
Study Overview
Brief Summary
Characterizing the nature and severity of tinnitus in individuals presents a particular challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. Different methods are used to measure each parameter. Loudness is measured using a technique called "minimum masking," in which the subject is presented with a broadband white noise and asked to adjust the loudness level until they can no longer hear their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These questionnaires assess the perceived severity of the tinnitus and the effect on everyday activities and quality of life. A visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. In the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual.
The second part will look at the influence of context-specific visual information on auditory perception. This involves watching silent videos of a person speaking, with and without an additional tone designed to match the subject's tinnitus. The effect of this audiovisual feedback on the subject's perception of tinnitus will be assessed using a subjective rating scale and the minimum masking task.
Detailed Description
This study is not specifically seeking to treat tinnitus, but is designed to investigate various parameters that can alter the tinnitus percept. Findings from this study will help identify parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have subjective, non-pulsatile and bothersome tinnitus
- •Ability to give informed consent and understand study objectives and procedures in English
- •Willing and able to understand and comply with all study-related procedures
- •Will not start any new tinnitus treatment during the study
Exclusion Criteria
- •Substantial hearing loss or hyperacusis that may interfere with the study
- •Medical history of other ear or brain disorders
- •Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety)
- •Any handicap that prevents the subject from reliably performing the tests, such as blindness.
Arms & Interventions
Characterization, Audiovisual
Characterization: Tinnitus characterization tools (Minimal Masking Level, Tinnitus Functional Index, Tinnitus Handicap Inventory, and Subjective rating scale) are assessed in an individual over time to determine baseline variability.
Audiovisual: The individual will watch a series of silent videos of a person speaking, both with and without a tone matched to their tinnitus as well as videos of a still face with and without the matched tone.
Intervention: Tone (Other)
Characterization, Audiovisual
Characterization: Tinnitus characterization tools (Minimal Masking Level, Tinnitus Functional Index, Tinnitus Handicap Inventory, and Subjective rating scale) are assessed in an individual over time to determine baseline variability.
Audiovisual: The individual will watch a series of silent videos of a person speaking, both with and without a tone matched to their tinnitus as well as videos of a still face with and without the matched tone.
Intervention: Video (Other)
Outcomes
Primary Outcomes
Change in Tinnitus Rating (0-10, 10 being worst)
Time Frame: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
the subject rates the disturbance or bothering nature of the tinnitus.
Change in Minimal Masking Level
Time Frame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Secondary Outcomes
- Change in Tinnitus Subjective Description(Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm)
- Change in Tinnitus Functional Index Questionnaire Score(Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm)
- Change in Tinnitus Handicap Inventory Questionnaire Score(Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm)