Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

Launched by UNIVERSITY OF MINNESOTA ·

Keywords

ClinConnect Summary

This trial is testing whether a non-invasive device called Lenire (sound through headphones plus gentle tongue stimulation) can help people with tinnitus after six weeks of daily use. Researchers will look at brain activity measured by a 32-channel EEG and also at changes in tinnitus symptoms and stress using standard questionnaires. The main goal (primary outcome) is to see how brain signals change after six weeks, and they’ll also explore how these brain changes relate to scores on the tinnitus and stress tests (lower scores are better).

Who can join? Adults 18 and older with subjective tinnitus that has lasted from 3 months to 20 years, who can understand English and give informed consent, and who can hear the Lenire device at its mid-range setting. For those in the treatment group, the baseline impact of tinnitus on daily life must be in a certain range (THI score 40–76). There are many safety-related exclusions (for example, pulsatile tinnitus, recent changes in certain medications, certain neurological conditions, implanted devices, pregnancy, etc.). The study will be conducted at the University of Minnesota in Minneapolis, aims to enroll about 24 people, is not yet recruiting (start around Oct 1, 2025), and is expected to finish around June 30, 2026.

Gender

ALL

Eligibility criteria