Tinnitus
Conditions
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.
Interventions
DEVICELenire Device
The Lenire device is a non-invasive stimulation system designed to reduce the symptoms of chronic subjective tinnitus. It includes a controller that is connected to headphones for sound delivery to the ears and a mouthpiece that provides mild electrical stimulation to the surface of the tongue. Users are recommended to use the device for 60 minutes daily, either in two consecutive 30-minute sessions or at different times throughout the day, for a minimum of 36 hours.
Sponsors
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in brain waves at 6 weeks | Week 6 | Assessed via 32-channel EEG recording |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeggy Nelson
University of Minnesota
Outcome results
None listed