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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02717065
• Other study ID #: 1512M81434
• Status: Withdrawn
• Phase: N/A
• First received: March 17, 2016
• Last updated: September 13, 2017
• Start date: June 2017
• Est. completion date: January 2018

Study information

• Verified date: September 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota, Nils Hasselmo Hall, 6-105	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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