Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

NCT07158034 | Recruiting FDA Device

• 1 other identifier: STUDY00025649
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in brain waves at 6 weeks

  Assessed via 32-channel EEG recording

  Week 6

Secondary Outcomes (1)

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

  Week 6

Study Arms (2)

Treatment Group

EXPERIMENTAL

Use Lenire device for 1 hour daily

Device: Lenire Device

Control Group

NO INTERVENTION

Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjective tinnitus
• Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group)
• Baseline THI score from 40 to 76 (only for participants in treatment group)
• Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)

You may not qualify if:

• 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
• A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss.
• History of auditory hallucinations
• Tumor on the hearing or balance nervous systems
• Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
• Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
• Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
• Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
• Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
• Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
• Participant with a pacemaker or other electro-active implanted device
• Participant previously diagnosed with psychosis or schizophrenia

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peggy Nelson

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yezihalem Mesfin

CONTACT

763-742-6236; mesri001@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)