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
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 THI score from 40 to 76 (treatment group only)
- Hearing loss condition that allows hearing the Lenire device's acoustic stimulation (treatment group only)
You will not qualify if you...
- Pulsatile subjective tinnitus as the dominant feature (treatment group only)
- Objective tinnitus
- Unable to hear the Lenire device's acoustic stimulation at mid-range volume
- Started wearing hearing aids within the past 3 months
- Diagnosed with Meniere's disease or other fluctuating hearing loss disorder
- History of auditory hallucinations
- Tumor on hearing or balance nervous systems
- Head or neck injury requiring hospitalization or physician visit in past 12 months
- Started, stopped, or changed dosage of certain medications (antidepressants, anticonvulsants, neuroleptics, opioid analgesics) in past 3 months
- Use of benzodiazepines or sedative hypnotics
- Neurological conditions causing seizures or loss of consciousness (e.g., epilepsy)
- Pacemaker or other electro-active implanted device
- Diagnosis of psychosis or schizophrenia
- Diagnosis of Burning Mouth Syndrome
- Diagnosis of bothersome temporomandibular joint disorder (TMJ)
- Previous tinnitus treatment trial or implantable/surgical tinnitus intervention
- Inability to physically or comprehensively use the device
- Oral piercings that cannot or will not be removed
- Pregnancy per patient report
- Prisoner
- Investigator deems candidate unsuitable for other reasons with rationale provided
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
Y
Yezihalem Mesfin
CONTACT
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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