Actively Recruiting
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
Led by University of Minnesota · Updated on 2025-10-14
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as objective measures to assess improvement in tinnitus following treatment. The study focuses on individuals with subjective tinnitus lasting between 3 months and 20 years. The purpose is to evaluate the changes in brain waves after six weeks of using a bimodal stimulation device called Lenire, which is designed to reduce symptoms of chronic tinnitus. Participants are divided into two groups. The treatment group will use the Lenire device daily for one hour, either in two 30-minute sessions or at different times, totaling at least 36 hours during the study. The device delivers sound through headphones and mild electrical stimulation to the tongue. The control group will not receive any stimulation or device use during the study period. This non-randomized, unblinded study is led by the University of Minnesota. Participants will be assessed at the start and after six weeks of treatment. Researchers will monitor brain wave changes as the primary outcome and explore correlations between EEG measures, auditory brainstem responses, tinnitus severity, and stress scales as secondary outcomes. Participants will provide informed consent and commit to the full study duration. The study includes safety monitoring and excludes certain health conditions and medication changes that could affect results.
CONDITIONS
Brief Title
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 3 months to 20 years (treatment group only)
- Baseline Tinnitus Handicap Inventory (THI) score from 40 to 76 (treatment group only)
- Hearing loss condition allowing perception of Lenire device acoustic stimulation (treatment group only)
You will not qualify if you...
- Subjective tinnitus with pulsatility as the dominant feature (treatment group only)
- Objective tinnitus
- Unable to hear Lenire device acoustic stimulation at mid-range volume
- Started wearing hearing aids within the last 3 months
- Diagnosed with Meniere's disease or fluctuating hearing loss disorder
- History of auditory hallucinations
- Tumor affecting hearing or balance nerves
- Head or neck injury requiring hospitalization or physician visit in last 12 months
- Recent changes (within 3 months) in certain prescription medications (antidepressants, anticonvulsants, neuroleptics, opioid analgesics)
- Regular or on-demand use of benzodiazepines or sedative hypnotics
- Neurological conditions causing seizures or loss of consciousness
- Pacemaker or other implanted electro-active device
- Previous diagnosis of psychosis or schizophrenia
- Diagnosed with Burning Mouth Syndrome
- Diagnosed with bothersome temporomandibular joint disorder (TMJ)
- Previous tinnitus treatment clinical trial participation or surgical intervention
- Physical or cognitive inability to use the device
- Oral piercings that cannot be removed
- Pregnancy (reported by patient)
- Prisoner
- Investigator deems candidate unsuitable for other reasons (with rationale)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants use the Lenire device, a non-invasive stimulation system designed to reduce the symptoms of chronic subjective tinnitus. The device is used for 60 minutes daily, either in two consecutive 30-minute sessions or at different times throughout the day, for a minimum of 36 hours.
Regular visits for device usage monitoring
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
Y
Yezihalem Mesfin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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