Cognitive Speed as an Objective Measure of Tinnitus

NCT01395368 | Completed Results

• 1 other identifier: 201103191
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

subjective; unilateral; bilateral; non-pulsatile; 6 month's duration or longer

Outcome Measures

Primary Outcomes (1)

• Brain Speed Test

  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.

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

Study Arms (1)

Brain Speed Test

Brain Speed Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Tinnitus subjects with moderate or greater depression were excluded from the study. This study may not be reflective of the population of bothersome tinnitus patients due to this exclusion

Results Point of Contact

• Title: Dr. Jay F. Piccirillo, Professor
• Organization: Washington University in St. Louis

piccirilloj@ent.wustl.edu

314 362-8641

Study Officials

• Jay F Piccirillo

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Washington University School of Medicine

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 23, 2012
• Results First Posted: August 23, 2012

Record last verified: 2012-07

Locations

US (1)