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Behavioural Intervention

Bimodal Stimulation Device for Tinnitus

N/A

Waitlist Available

Led By Meredith Adams, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years and over at time of consent

Be older than 18 years old

Must not have

Objective tinnitus

Health care provider has rendered a diagnosis of Meniere's disease or other disorder with fluctuating hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device to help with symptoms of chronic subjective tinnitus. The device, called Lenire, is a non-invasive stimulator that is worn in the mouth and delivers electrical stimulation to the tongue surface. It is also worn with headphones that deliver sound to the ears. The device is used for two 30-minute sessions each day, for a total of 60 minutes daily. The objective of the study is to assess compliance and satisfaction with the device, with the hope that it will help a larger population of people who suffer from tinnitus.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While previous trials showed minimal risk with high compliance and satisfaction rates using Lenire, potential side effects are not detailed here but may include discomfort from earphones or tongue stimulator based on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I hear noises in my ears that others can hear too.

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I have been diagnosed with Meniere's disease or a similar condition causing varying levels of hearing loss.

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I have been diagnosed with extreme sensitivity to sounds.

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My tumor affects my hearing or balance nerves.

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I have been to a doctor or hospital for a head or neck injury in the last year.

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I haven't started any new medications like antidepressants or painkillers in the last 3 months.

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I use benzodiazepines or sedative hypnotics.

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I have a condition like epilepsy that could cause seizures or make me pass out.

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I have been diagnosed with Burning Mouth Syndrome.

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I have been diagnosed with a problematic TMJ condition.

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I have not participated in any tinnitus treatment studies or had surgery for it.

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I cannot use the device due to physical or comprehension issues.

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I have oral piercings that I cannot or will not remove.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compliance rate after 12 weeks of bimodal stimulation

Secondary study objectives

Satisfaction rate after 12 weeks of bimodal stimulation

Other study objectives

Impact of the stimulation device on anxiety after 12 weeks of bimodal stimulation

Acoustic Stimulation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single study armExperimental Treatment1 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.

0 / 14Eligibility criteria met