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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT06821893
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Ability to read, write, speak, and understand English
* Bothersome tinnitus with initial TSSF score greater than 40 on screening
* Available for the entire period of the study including one month follow-up after completion of 8-week intervention period
* Access to internet-connected device(s) such as phone, tablet, or laptop with a camera
Exclusion Criteria:
* Age\>70
* Pregnant or planning to become pregnant during the study period
* Previous participation in an auricular stimulation trial
* Currently on active treatment for tinnitus
* Have cochlear implant or other device that impedes usage of auricular stimulation device
* Tinnitus related to ear surgery, Meniere's disease, ear infections, or other ear pathology
* Substance abuse
* Unstable psychiatric disorders
* Patient Health Questionnaire (PHQ-9) score greater than 9 History of brain surgery
* History of traumatic brain injury
* History of bradycardia or bradyarythmias
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06821893
Study Brief:
Protocol Section:
NCT06821893