Cognitive Speed as an Objective Measure of Tinnitus (COMeT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01395368
First received: July 13, 2011
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition
Tinnitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Speed as an Objective Measure of Tinnitus

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Brain Speed Test [ Time Frame: Participants completed brain speed test on the same day as enrollment. No follow-up required. ] [ Designated as safety issue: No ]
    Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.


Enrollment: 108
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Brain Speed Test
Brain Speed Test

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will include men and women between the ages of 18-80 years who have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395368

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jay F Piccirillo Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University School of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01395368     History of Changes
Other Study ID Numbers: 201103191
Study First Received: July 13, 2011
Results First Received: April 13, 2012
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
subjective
unilateral
bilateral
non-pulsatile
6 month's duration or longer

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014