Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

ConditionTinnitus

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years and over at time of consent

Ability to read and understand English

Willing and able to provide and understand informed consent

Willing to commit to the full duration of the investigation

Disqualifiers

Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group)

Objective tinnitus

Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting

Began wearing hearing aids within the past 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Treatment GroupExperimental treatment 1 intervention

Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in brain waves at 6 weeks

Assessed via 32-channel EEG recording

Time frame

Week 6

Secondary outcomes

Correlation between change in EBDBE, ABR, THI, and PSS-10

Assessed via Tinnitus Handicap Inventory (THI) and Perceived Stress Scale (PSS), for which lower scores indicate a better outcome.

Time frame

Week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

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