NCT07158034 Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
| NCT ID | NCT07158034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-10-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Treatment 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 * 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.
Contact & Investigator
Peggy Nelson
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07158034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07158034 currently recruiting?
Yes, NCT07158034 is actively recruiting participants. Contact the research team at mesri001@umn.edu for enrollment information.
Where is the NCT07158034 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07158034 clinical trial?
NCT07158034 is sponsored by University of Minnesota. The principal investigator is Peggy Nelson at University of Minnesota. The trial plans to enroll 24 participants.