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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance rate after 12 weeks of bimodal stimulation
Secondary outcome measures
Satisfaction rate after 12 weeks of bimodal stimulation
Other outcome measures
Impact of the stimulation device on anxiety after 12 weeks of bimodal stimulation
Acoustic Stimulation
Acoustic Stimulation
+1 moreTrial 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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,588,250 Total Patients Enrolled
3 Trials studying Tinnitus
33 Patients Enrolled for Tinnitus
Neuromod Devices LimitedUNKNOWN
Kent TaylorUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have hearing loss.I have been diagnosed with Burning Mouth Syndrome.My tinnitus has lasted for more than 3 months but less than 20 years.I have a middle ear problem, such as hearing loss or a history of surgery.I hear noises in my ears that others can hear too.I have been to a doctor or hospital for a head or neck injury in the last year.I have been diagnosed with Meniere's disease or a similar condition causing varying levels of hearing loss.I haven't started any new medications like antidepressants or painkillers in the last 3 months.I have not participated in any tinnitus treatment studies or had surgery for it.I am 18 years old or older.My tumor affects my hearing or balance nerves.Your initial THI score is between 38 and 76.I haven't taken antidepressants, anticonvulsants, neuroleptics, or opioids in the last 3 months.You are pregnant.You started using hearing aids in the last 3 months.I have been diagnosed with extreme sensitivity to sounds.You have experienced hearing things that aren't really there.I have a condition like epilepsy that could cause seizures or make me pass out.You have a pacemaker or another implanted device that uses electricity.You are currently or have been involved in legal cases related to medical issues.I cannot use the device due to physical or comprehension issues.I hear ringing or noise in my ears that others don't.I have been diagnosed with a problematic TMJ condition.I experience a pulsing sound in my ears that isn't caused by an external noise.I have oral piercings that I cannot or will not remove.
Research Study Groups:
This trial has the following groups:- Group 1: Single study arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tinnitus Patient Testimony for trial: Trial Name: NCT05518682 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for participants in this experiment?
"According to information on clinicaltrials.gov, this research is not currently open for recruitment. It was initially posted on September 19th 2022 and the most recent update occurred November 18th 2022. However, 45 other studies are accepting participants presently."
Answered by AI
Who else is applying?
What state do they live in?
California
Minnesota
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Minnesota - TESSLab/PWB
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0
Why did patients apply to this trial?
TINIITUS IS A BURDEN. Looking for solution for my Tinnitus. I want to do something about the Tinnitus.
PatientReceived 1 prior treatment
I’m interested in helping to find a Tinnitus cure. Im very interested to a treatment that might work.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When can I start? Can I do this trial from home? How long will the screenings take?
PatientReceived no prior treatments
Is there anything close to Raleigh, NC?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- University of Minnesota - TESSLab/PWB: < 48 hours
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