Clinical trial NCT01395368: Cognitive Speed as an Objective Measure of Tinnitus
Official title: Cognitive Speed as an Objective Measure of Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Keywords: subjective
unilateral
bilateral
non-pulsatile
6 month's duration or longer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Brain Speed Test
timeFrame: Participants completed brain speed test on the same day as enrollment. No follow-up required.
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay F Piccirillo
role: PRINCIPAL_INVESTIGATOR
References: