Clinical Trial: Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception

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 Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Tinnitus Functional Index Questionnaire Score [ Time Frame: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm ]
  A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
• Change in Tinnitus Handicap Inventory Questionnaire Score [ Time Frame: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm ]
  A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
• Change in Tinnitus Subjective Description [ Time Frame: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm ]
  The subject describes the quality, characteristics, and bothering nature of the tinnitus.

Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: March 17, 2016
Date Started: June 2017
Date Completion: January 2018
Last Updated: March 3, 2017
Last Verified: March 2017