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Tinnitus Implant for Tinnitus
N/A
Waitlist Available
Led By Matthew L Carlson, MD
Research Sponsored by Matthew L. Carlson, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is testing a new implant to see if it's safe and effective in treating tinnitus.
Who is the study for?
Adults over 18 with severe, persistent tinnitus not helped by usual treatments like hearing aids. They should have had tinnitus for at least 6 months but no more than 3 years, and have a certain level of hearing loss and speech recognition ability.Check my eligibility
What is being tested?
The trial is testing the Tinnitus Implant System to see if it's safe and works for treating chronic severe tinnitus. Participants will receive this novel device designed specifically for those who haven't found relief through conventional methods.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information. However, as with any implant procedure or device, there could be risks such as infection, discomfort at the implant site, or worsening of symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects to experience significant improvement from implantation of the device
Number of subjects with treatment-related adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subject with severe tinnitusExperimental Treatment1 Intervention
Subjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System.
Find a Location
Who is running the clinical trial?
Matthew L. Carlson, M.D.Lead Sponsor
Matthew L Carlson, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You experience tinnitus in only one ear or the sound is louder in one ear compared to the other.You have a normal CT scan of your temporal bone.You must be 18 years old or older.Your score on the PHQ-8 test is higher than 9, which means you may have significant depression.You have a high level of anxiety about being sick.You are currently taking medications for depression, anxiety, or mental illness.You are currently using other treatments for tinnitus, except for non-masking hearing aids.You are unable to participate in, stay in, or finish the trial.You have had tinnitus for less than 6 months or longer than 3 years.You are currently pregnant.Your score on the GAD-7 anxiety test is higher than 9, which means you have significant anxiety.Your head MRI shows no unusual changes when a special dye is used.Your hearing loss is not severe (less than or equal to 70 decibels) and you can understand speech well (word recognition score of at least 75%).You have had tinnitus for at least 6 months but not longer than 3 years.You have had a serious head injury in the past.You have significant symptoms of depression or anxiety based on specific screening tests.You have bothersome tinnitus.Your THI score is very high, at least 56 out of 100.Your TFI score is very high, 52 out of 100 or more.You have severe tinnitus, rated at 50 out of 100 or higher.You have constant ringing in your ears that hasn't improved with regular treatments like a hearing aid or sound masking.
Research Study Groups:
This trial has the following groups:- Group 1: Subject with severe tinnitus
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: NCT03988699 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still able to apply for participation in this research?
"The clinical trial registry hosted on clinicaltrials.gov shows that patient recruitment for this particular medical study has ended, with the initial posting of August 23rd 2021 and the most recent update occuring July 14th 2022. Despite this, 45 other trials are still actively recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
Florida
California
Minnesota
Other
How old are they?
65+
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0
What questions have other patients asked about this trial?
what are they doing in this trial? When will you be starting the study? How long does thisvtake? How many visits are necessary ?
PatientReceived no prior treatments
Can you put an implant on an ear that has already been cut open in 1995?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I’m very motivated to work for a solution to. Tendinitis interferes with my quality of life.
PatientReceived no prior treatments
i become really creazy from this sound in my ear/brain! I have been bothered for years, it is effecting my work and home life, constantly having to ask people to repeat what they have said.
PatientReceived 1 prior treatment
I've had this problem for a while and I haven't heard silence for years. I'm very tired of the constant frequencies playing in my head.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Mayo Clinic in Rochester: < 48 hours
Average response time
- < 2 Days
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