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Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

NCT07158034 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-14

No results posted yet for this study

Summary

The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.

Conditions

  • Tinnitus

Interventions

DEVICE

Lenire Device

The Lenire device is a non-invasive stimulation system designed to reduce the symptoms of chronic subjective tinnitus. It includes a controller that is connected to headphones for sound delivery to the ears and a mouthpiece that provides mild electrical stimulation to the surface of the tongue. Users are recommended to use the device for 60 minutes daily, either in two consecutive 30-minute sessions or at different times throughout the day, for a minimum of 36 hours.

Sponsors & Collaborators

Principal Investigators

  • Peggy Nelson · University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158034 on ClinicalTrials.gov