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

NCT02717065 | Withdrawn

• 1 other identifier: 1512M81434
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Neuromodulation; Noninvasive; Plasticity; Hearing; Hyperacusis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• Change in Tinnitus Subjective Description

  Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm

Study Arms (1)

Characterization, Audiovisual

EXPERIMENTAL

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; Other: Video

Interventions

Tone OTHER

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

Characterization, Audiovisual

Video 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.

Characterization, Audiovisual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota, Nils Hasselmo Hall, 6-105

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tinnitus; Hyperacusis

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Hubert Lim, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 23, 2016
• Study Start: June 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)