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Cognitive Speed as an Objective Measure of Tinnitus (COMeT)

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The Washington University

Status

Completed

Conditions

Tinnitus

Study type

Observational

Funder types

Other

Identifiers

NCT01395368
201103191

Details and patient eligibility

About

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.

Full description

This was a cross-sectional study designed to investigate the relationship that self-reported tinnitus severity has with cognitive processing speed and psychiatric factors

Enrollment

108 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 determines would compromise the safety of the participant or complicate the interpretation of the study results.

Trial design

108 participants in 1 patient group

Brain Speed Test
Description:
Brain Speed Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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