WithdrawnNot Applicable

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

Stopped: Personnel and funding was no longer available

United States0Started 2017-06

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Minimal Masking Level

Timeframe: 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)

Timeframe: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm

Trial details

NCT IDNCT02717065

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01

View on ClinicalTrials.gov More Tinnitus trials