Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT01395368
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01395368
Study Brief:
Protocol Section:
NCT01395368