Back to resultsNovel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
Primary Purpose
Tinnitus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tinnitus Implant System
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria
- Age: ≥18 years of age
- Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥ 75%.
- Unilateral or asymmetrical subjective tonal tinnitus
- Tinnitus present for at least 6 months, but not longer than 3 years
Tinnitus that is disruptive
- THI score in the severe range (≥56/100)
- TFI score in the severe range (≥52/100)
- Tinnitus VAS ≥50/100
- Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking
Exclusion Criteria
- Age: <18 years of age
- Tinnitus present less than 6 months or longer than 3 years
- Current pregnancy
- History of brain or major ear surgery
Prior major head trauma
Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHAI
- GAD-7 >9 (indicates clinically significant anxiety)
- PHQ-8 >9 (indicates clinically significant depression)
- SHAI >25 (hypochondriacal level illness anxiety)
- Inability to assess, continue or complete trial
- Currently on antidepressants, anxiolytics or antipsychotics
- Active use of other tinnitus treatments (not including non-masking hearing aid use)
- Normal contrast-enhanced MRI of the head
- Normal temporal bone CT
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subject with severe tinnitus
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of subjects with treatment-related adverse events
Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (>10 dB) or worsening in WRS from baseline by a clinically significant amount (>20%) or worsening in video head impulse test result from baseline or one or more serious AEs
Number of subjects to experience significant improvement from implantation of the device
Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988699
Brief Title
Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
Official Title
Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew L. Carlson, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.
Detailed Description
This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subject with severe tinnitus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tinnitus Implant System
Intervention Description
Device will deliver stimulation below hearing thresholds continuously or intermittently.
Primary Outcome Measure Information:
Title
Number of subjects with treatment-related adverse events
Description
Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (>10 dB) or worsening in WRS from baseline by a clinically significant amount (>20%) or worsening in video head impulse test result from baseline or one or more serious AEs
Time Frame
One year
Title
Number of subjects to experience significant improvement from implantation of the device
Description
Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain.
Time Frame
Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age: ≥18 years of age
Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥ 75%.
Unilateral or asymmetrical subjective tonal tinnitus
Tinnitus present for at least 6 months, but not longer than 3 years
Tinnitus that is disruptive
THI score in the severe range (≥56/100)
TFI score in the severe range (≥52/100)
Tinnitus VAS ≥50/100
Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking
Exclusion Criteria
Age: <18 years of age
Tinnitus present less than 6 months or longer than 3 years
Current pregnancy
History of brain or major ear surgery
Prior major head trauma
Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHAI
GAD-7 >9 (indicates clinically significant anxiety)
PHQ-8 >9 (indicates clinically significant depression)
SHAI >25 (hypochondriacal level illness anxiety)
Inability to assess, continue or complete trial
Currently on antidepressants, anxiolytics or antipsychotics
Active use of other tinnitus treatments (not including non-masking hearing aid use)
Normal contrast-enhanced MRI of the head
Normal temporal bone CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew L Carlson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
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