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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT04661995
Eligibility Criteria:
Inclusion Criteria:
Candidates must meet the following inclusion criteria to qualify:
* Veteran
* no active middle-ear disease
* at least one air conduction hearing threshold of 40 dB HL or worse in each ear between .25-8 kHz as measured at the first study visit
* unilateral or bilateral constant tinnitus
* index score on the Tinnitus Functional Index (TFI) of at least 25 (out of a maximum score of 100)
* a score of 24 or higher on the Mini Mental State Exam (MMSE)
* a tinnitus pitch match between 2-10 kHz (and achieve desired level of precision as described below in 3.3 Study Procedures, Tinnitus Psychoacoustic Assessment)
* demonstrates understanding of the requirements of the study
* motivated and capable of participating (including ability to communicate in English)
Exclusion Criteria:
The following exclusion criteria will be used:
* two or more hearing thresholds exceeding 70 dB HL
* significant conductive hearing loss-defined as an air-bone gap of 15 dB at more than two frequencies in one ear, or an air-bone gap greater than 15 dB at any one frequency
* suspicion of secondary (somatic) tinnitus, Meniere's disease, or tinnitus potentially related to temporo-mandibular disorder or whiplash (any of which can be ruled out with an examination by an appropriate physician)
* any mental, emotional, or health conditions that would preclude full study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04661995
Study Brief:
Protocol Section:
NCT04661995