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

NCT ID: NCT02717065

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-01-31

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.

Conditions

Tinnitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tone

Intervention Type: OTHER

Band-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones.

Video

Intervention Type: OTHER

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.

Interventions

Tone

Band-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert Lim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota, Nils Hasselmo Hall, 6-105

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1512M81434

Identifier Type: -

Identifier Source: org_study_id