TinnitusNCT07158034
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
A study testing Lenire Device in people with Tinnitus, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Lenire Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Tinnitus
- Being tested
- Lenire Device
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenire DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Use Lenire device for 1 hour daily Receives: Device: Lenire Device |
| Control Group | No intervention | Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain waves at 6 weeks
Assessed via 32-channel EEG recording
Measured: Week 6
Secondary outcomes (1)
Correlation between change in EBDBE, ABR, THI, and PSS-10
Assessed via Tinnitus Handicap Inventory (THI) and Perceived Stress Scale (PSS), for which lower scores indicate a better outcome.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start3 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy Nelson, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158034
- Sponsor's protocol ID
- STUDY00025649
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
- ClinicalTrials.gov ID
- NCT07158034
- Acronym / sponsor ID
- STUDY00025649
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Lenire DeviceUse Lenire device for 1 hour daily |
| Control Group | No intervention | –Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenire DeviceThe 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. | Device | Treatment Group |
Primary outcome
Change in brain waves at 6 weeks
Time frame: Week 6
Assessed via 32-channel EEG recording
1 secondary outcome
Correlation between change in EBDBE, ABR, THI, and PSS-10
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Nelson principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenire Device in people with Tinnitus, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain waves at 6 weeks (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.