Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

NCT ID: NCT07158034

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-03
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Use Lenire device for 1 hour daily

Group Type: EXPERIMENTAL

Lenire Device

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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)

• 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

Exclusion Criteria

• 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
• Participants diagnosed with Burning Mouth Syndrome
• A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
• Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
• Inability to physically or comprehensively use the device
• Oral piercings that cannot or will not be removed
• Pregnancy per patient report
• Prisoner
• PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.

• Began wearing hearing aids within the past 3 months
• 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 previously diagnosed with psychosis or schizophrenia
• A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
• Prisoner
• PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peggy Nelson

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yezihalem Mesfin

Role: CONTACT

mesri001@umn.edu

763-742-6236

Facility Contacts

Yezihalem Mesfin

Role: primary

mesri001@umn.edu

763-742-6236

Other Identifiers

STUDY00025649

Identifier Type: -

Identifier Source: org_study_id