Status:
RECRUITING
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
Lead Sponsor:
University of Minnesota
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 tinnit...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07158034
Start Date
October 3 2025
End Date
June 30 2026
Last Update
October 14 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455