Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
Recruiting
N/AInterventional Study
Tinnitus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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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 o…
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.
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