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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
Subjective tinnitus
Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upenrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit
Awards & highlights
No Placebo-Only Group
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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have ringing or buzzing in your ears.
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You have had tinnitus for at least 3 months but no more than 20 years when you agree to join the study.
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Your initial THI score is between 38 and 76.
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You have hearing loss.
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 moreAwards & 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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,339 Previous Clinical Trials
1,582,347 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:- You have experienced tinnitus for at least 3 months but no more than 20 years when you give your permission to participate.You must be 18 years old or older when giving your agreement to participate.You have ringing in your ears.Your initial THI score is between 38 and 76.Criterion: You have a hearing loss condition.You have access to a reliable internet connection and a device capable of accessing the Internet.You have ringing in your ears that gets louder with your heartbeat.You have a specific, identifiable sound in your ears that can be heard by others.You have a documented ear condition that causes hearing loss or have had surgery on your middle ear.You started using hearing aids in the last 3 months.You have been diagnosed with Meniere's disease or another condition that causes your hearing to go up and down.You have been diagnosed with extreme sensitivity to loud noises or certain sounds.You have experienced hearing things that aren't really there in the past.You have a tumor on the nerves related to hearing or balance.You have been to the hospital or seen a doctor for a head or neck injury in the past year.You are currently using benzodiazepines or sedative medications regularly or as needed.You have a condition that may cause seizures or loss of consciousness, like epilepsy.You have a pacemaker or another implanted device that uses electricity.You have been diagnosed with psychosis or schizophrenia in the past.Your initial THI score is between 38 and 76.You have either mild or severe hearing loss.You have been diagnosed with Burning Mouth Syndrome.You have been diagnosed with a bothersome temporomandibular joint disorder (TMJ).You have participated in a study for tinnitus treatment before, or have had surgery or an implant for tinnitus.You are currently or have been involved in legal cases related to medical issues.You are pregnant, according to what you tell us.You have ringing or buzzing in your ears.You have had tinnitus for at least 3 months but no more than 20 years when you agree to join the study.Your initial THI score is between 38 and 76.You have hearing loss.You experience ringing or buzzing in your ears.You have had ringing in your ears for at least 3 months but no more than 20 years when you agree to join the study.
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?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- University of Minnesota - TESSLab/PWB: < 48 hours
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