Clinical trial NCT02717065: Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
Official title: Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tinnitus
Keywords: Neuromodulation
Noninvasive
Plasticity
Hearing
Hyperacusis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Minimal Masking Level
timeFrame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
measure: Change in Tinnitus Rating (0-10, 10 being worst)
timeFrame: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Secondary outcomes:
measure: Change in Tinnitus Functional Index Questionnaire Score
timeFrame: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
measure: Change in Tinnitus Handicap Inventory Questionnaire Score
timeFrame: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
measure: Change in Tinnitus Subjective Description
timeFrame: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Nils Hasselmo Hall, 6-105
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Hubert Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References: