Cognitive Speed as an Objective Measure of Tinnitus

Tinnitus Clinical Trial

— COMeT  

Official title:

Cognitive Speed as an Objective Measure of Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395368
• Other study ID #: 201103191
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: July 18, 2012
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: July 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tinnitus

Locations

Country	Name	City	State
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No