Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07158034
Status
Recruiting
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Conditions

  • Tinnitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lenire Device — 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.

Study Details

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.

Key Dates

First listed
Sep 5, 2025
Start date
Oct 3, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    Use Lenire device for 1 hour daily
  • No Intervention: Control Group
    Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.

Primary Outcome Measure

Change in brain waves at 6 weeks [ Time Frame: Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Yezihalem Mesfin
[email protected]
763-742-6236

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By research site
University of Minnesota· Minneapolis, MN

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