Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

Not Applicable

Not yet recruiting

• Conditions: Tinnitus

• Registration Number: NCT07158034
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-10-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Treatment Group

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.

Control Group 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

Control Group Exclusion Criteria:

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in brain waves at 6 weeks	Week 6	Assessed via 32-channel EEG recording

Secondary Outcome Measures

Name	Time	Method
Correlation between change in EBDBE, ABR, THI, and PSS-10	Week 6	Assessed via Tinnitus Handicap Inventory (THI) and Perceived Stress Scale (PSS), for which lower scores indicate a better outcome.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States