CompletedNot Applicable

Cognitive Speed as an Objective Measure of Tinnitus

United States108 participantsStarted 2011-06

Plain-language summary

Tinnitus, commonly referred to as "ringing in the ears", affects 50 million people in the United States and is recognized as a major public health concern. Tinnitus is the most frequent cause of service-connected disability claims among war veterans. Tinnitus remains a subjectively diagnosed entity. There is no standardized objective method of diagnosing tinnitus or describing the functional impact of the condition. Currently, physicians have to rely on patient-based self reports. Without an objective method of diagnosing tinnitus and describing the functional implications, adequate treatment delivery is also hampered since there is no way to objectively stratify patients into severity groups and assess response to treatment. Because tinnitus is known to negatively affect cognition through the ventral attention networks and the prefrontal cortex, measuring cognitive processing speed is a possible way to objectively measure tinnitus. This study builds on previous work the investigators have done that utilized a quick, easily accessible measure of auditory processing speed. That earlier study showed a correlation between that measure and self reported measures of tinnitus severity, and this study attempts determine a more precise estimate of that correlation. It also better validates those results by including a traditional neurocognitive measuring cognitive speed and by controlling for the presence of depression and somatoform disorders.

Who can participate

Age range

18 Years – 80 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: * Participants must be between the ages of 18 and 80. * Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer. * Participants must be able to read, write and speak using the English language. * Participants must be able to read and follow the instructions for both computerized tests, "The Brain Speed Test" and "The 60 Second Brain Game." * Participants must be able to provide written informed consent. Exclusion Criteria: * Participants with tinnitus related to Workman's Compensation Claim or other litigation-related situations. * Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia. * Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear. * Participants who have a hearing threshold above 90 dB on any of the tested frequencies during audiometry. * Participants unable to hear the highest volume of the computer-based objective assessments. * Participants taking any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates. * Participants with any medical condition the PI det…

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

Brain Speed Test

Timeframe: Participants completed brain speed test on the same day as enrollment. No follow-up required.

Trial details

NCT IDNCT01395368

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-10

Results submitted2012-04-13

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