Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception

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.

Study Overview

• Status: Withdrawn
• Conditions: Tinnitus
• Intervention / Treatment: Other: Tone; Other: Video

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota, Nils Hasselmo Hall, 6-105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Tone; Band-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones.; Other: Video; Silent video recording of a person speaking or a still face with an expanding circle over the mouth presented on a computer or tablet screen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Minimal Masking Level	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 baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
Change in Tinnitus Rating (0-10, 10 being worst)	the subject rates the disturbance or bothering nature of the tinnitus.	Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Hubert Lim, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Neuromodulation; Plasticity; Hearing; Noninvasive; Hyperacusis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 1512M81434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No