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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT03759834
Eligibility Criteria:
Inclusion Criteria:
1. Normal to moderate sensorineural hearing loss (based on pure tone audiometry (PTA) of 500, 1000 and 2000 Hz) and a word recognition score equal to or greater than 60%
2. Asymmetric or unilateral subjective tonal tinnitus
3. Tinnitus that is disruptive
1. Determined by THI score (in the severe range i.e. ≥56/100)
2. TFI (in the severe range i.e. ≥52/100)
3. Tinnitus VAS (≥ 5/10 )
4. Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking
5. Normal contrast-enhanced MRI of the head
Exclusion Criteria:
1. Tinnitus present less than 6 months or longer than 12 years; it is permissible to include people who have had intermittent or constant tinnitus longer than 12 years as long as it was not perceived as severe longer than 12 years
2. History of brain or major ear surgery
3. Prior major head trauma
4. Ongoing clinical diagnosis of depression or anxiety; for the purposes of this study, it is permissible to include people who: 1. have a past history of clinically diagnosed depression or anxiety that is no longer currently active; or 2. people who have depressive or anxious symptoms that are thought to primarily result from severe tinnitus
a. Determined by screening using the GAD 7, PHQ8, and HAI-S
* GAD7 \> 9 (indicates clinically significant anxiety)
* PHQ \> 9 (indicates clinically significant depression)
* HAI-S \> 25 (hypochondriacal level illness anxiety)
5. Inability to assess, continue or complete trial
6. Currently on regularly scheduled antidepressants, anxiolytics or antipsychotics; for this study, it is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel)
7. Active use of other tinnitus treatments; for the purposes of this study it is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss
8. Known pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03759834
Study Brief:
Protocol Section:
NCT03759834