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

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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