Bimodal Stimulation Device for Tinnitus

Overseen By Yezihalem Mesfin, MSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Antidepressants, Anticonvulsants, Neuroleptics, Opioids

Disqualifiers: Meniere's, Hyperacusis, Epilepsy, Schizophrenia, TMJ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the ability to self-adjust the sound stimulus presented to the ears via headphones. In particular, the CE marked bimodal stimulation portable device, Lenire, which is developed by Neuromod Devices Limited (Dublin, Ireland) to alleviate the symptoms of chronic subjective tinnitus, is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during fitting in a hearing center. Lenire device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 10 weeks. Lenire is already commercialized across Europe and available by audiologists or hearing technicians in numerous hearing centers for treating tinnitus. It has also been evaluated in two large-scale clinical trials in over 500 tinnitus participants, demonstrating tinnitus benefit and minimal risk with high compliance and satisfaction rates. The primary objective of the proposed usability study is to first assess compliance and satisfaction with the Lenire device that does not require an audiogram for fitting and that can be implemented mostly through virtual visits (except for the first visit). These modifications to the Lenire fitting process will reduce the time and personnel effort required for its implementation, enabling a broader patient population to access bimodal stimulation for tinnitus treatment, including military personnel and those who are not nearby hearing centers for in-person sessions. High compliance and satisfaction rates from this small proof-of concept usability study will then justify and guide a larger clinical study to assess efficacy and performance of this newly implemented Lenire device process.

Who Is on the Research Team?

Meredith Adams, MD

Principal Investigator

University of Minnesota

Peggy Nelson, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults over 18 with chronic subjective tinnitus for 3-20 years, a specific Tinnitus Handicap Inventory (THI) score range, and varying degrees of hearing loss can join. They must read English, consent to the study's duration, have internet access for virtual visits/surveys, and not be involved in other tinnitus studies or treatments.

Inclusion Criteria

I have hearing loss.

Willing and able to provide and understand informed consent

My tinnitus has lasted for more than 3 months but less than 20 years.

Exclusion Criteria

I haven't changed my medication for depression, seizures, psychosis, or pain in the last 3 months.

I use benzodiazepines or sedative hypnotics.

You have been diagnosed with psychosis or schizophrenia in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use the Lenire device for 60 minutes daily for 12 weeks, with adjustments to the headphone volume allowed

12 weeks

1 visit (in-person), mostly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Lenire bimodal stimulation device

Trial Overview The Lenire bimodal stimulation device is being tested for user compliance and satisfaction without needing an audiogram fitting. It delivers sound to ears via headphones and electrical stimulation to the tongue. Participants use it daily for at least 10 weeks mostly through virtual visits.

How Is the Trial Designed?

Group I: Single study arm Experimental Treatment 1 Intervention

The Lenire device is CE marked in Europe and intended to reduce the symptoms of tinnitus. It comprises a handheld controller and an intra-oral device called a Tonguetip® Intra-Oral Device (IOD), which delivers gentle electrical stimulation to the tongue, and also comprises of a set of wireless consumer headphones that deliver audio stimulation. The sound and tongue stimulus parameters such as stimulus rate, stimulus intensity, and the timing relationship between the auditory and somatosensory stimulus events are grouped into stimulation Parameter Sets (PS). PS1 is used during the first 6-weeks of stimulation and PS4 is used during the second 6-weeks of stimulation, similar to what is routinely used for tinnitus individuals in Europe. For this study, the device software has been modified to allow users to adjust the headphone volume to a level that is comfortable and clearly audible instead of a preset volume with limited adjustments based on the patient's audiogram.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Neuromod Devices Limited

Collaborator

Trials

1

Recruited

50+

Kent Taylor

Collaborator

Trials

1

Recruited

50+