Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
Primary Purpose
Tinnitus
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tone
Video
Sponsored by
About this trial
This is an interventional other trial for Tinnitus focused on measuring Neuromodulation, Noninvasive, Plasticity, Hearing, Hyperacusis
Eligibility Criteria
Inclusion Criteria:
- Have subjective, non-pulsatile and bothersome tinnitus
- Ability to give informed consent and understand study objectives and procedures in English
- Willing and able to understand and comply with all study-related procedures
- Will not start any new tinnitus treatment during the study
Exclusion Criteria:
- Substantial hearing loss or hyperacusis that may interfere with the study
- Medical history of other ear or brain disorders
- Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety)
- Any handicap that prevents the subject from reliably performing the tests, such as blindness.
Sites / Locations
- University of Minnesota, Nils Hasselmo Hall, 6-105
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Characterization, Audiovisual
Arm Description
Characterization: Tinnitus characterization tools (Minimal Masking Level, Tinnitus Functional Index, Tinnitus Handicap Inventory, and Subjective rating scale) are assessed in an individual over time to determine baseline variability. Audiovisual: The individual will watch a series of silent videos of a person speaking, both with and without a tone matched to their tinnitus as well as videos of a still face with and without the matched tone.
Outcomes
Primary Outcome Measures
Change in Minimal Masking Level
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Change in Tinnitus Rating (0-10, 10 being worst)
the subject rates the disturbance or bothering nature of the tinnitus.
Secondary Outcome Measures
Change in Tinnitus Functional Index Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Change in Tinnitus Handicap Inventory Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Change in Tinnitus Subjective Description
The subject describes the quality, characteristics, and bothering nature of the tinnitus.
Full Information
NCT ID
NCT02717065
First Posted
March 17, 2016
Last Updated
September 13, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02717065
Brief Title
Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
Official Title
Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Personnel and funding was no longer available
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Characterizing the nature and severity of tinnitus in individuals presents a particular challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. Different methods are used to measure each parameter. Loudness is measured using a technique called "minimum masking," in which the subject is presented with a broadband white noise and asked to adjust the loudness level until they can no longer hear their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These questionnaires assess the perceived severity of the tinnitus and the effect on everyday activities and quality of life. A visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. In the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual.
The second part will look at the influence of context-specific visual information on auditory perception. This involves watching silent videos of a person speaking, with and without an additional tone designed to match the subject's tinnitus. The effect of this audiovisual feedback on the subject's perception of tinnitus will be assessed using a subjective rating scale and the minimum masking task.
Detailed Description
This study is not specifically seeking to treat tinnitus, but is designed to investigate various parameters that can alter the tinnitus percept. Findings from this study will help identify parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Neuromodulation, Noninvasive, Plasticity, Hearing, Hyperacusis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Characterization, Audiovisual
Arm Type
Experimental
Arm Description
Characterization: Tinnitus characterization tools (Minimal Masking Level, Tinnitus Functional Index, Tinnitus Handicap Inventory, and Subjective rating scale) are assessed in an individual over time to determine baseline variability.
Audiovisual: The individual will watch a series of silent videos of a person speaking, both with and without a tone matched to their tinnitus as well as videos of a still face with and without the matched tone.
Intervention Type
Other
Intervention Name(s)
Tone
Intervention Description
Band-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones.
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
Silent video recording of a person speaking or a still face with an expanding circle over the mouth presented on a computer or tablet screen.
Primary Outcome Measure Information:
Title
Change in Minimal Masking Level
Description
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Time Frame
Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
Title
Change in Tinnitus Rating (0-10, 10 being worst)
Description
the subject rates the disturbance or bothering nature of the tinnitus.
Time Frame
Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Secondary Outcome Measure Information:
Title
Change in Tinnitus Functional Index Questionnaire Score
Description
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Time Frame
Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
Title
Change in Tinnitus Handicap Inventory Questionnaire Score
Description
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Time Frame
Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
Title
Change in Tinnitus Subjective Description
Description
The subject describes the quality, characteristics, and bothering nature of the tinnitus.
Time Frame
Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have subjective, non-pulsatile and bothersome tinnitus
Ability to give informed consent and understand study objectives and procedures in English
Willing and able to understand and comply with all study-related procedures
Will not start any new tinnitus treatment during the study
Exclusion Criteria:
Substantial hearing loss or hyperacusis that may interfere with the study
Medical history of other ear or brain disorders
Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety)
Any handicap that prevents the subject from reliably performing the tests, such as blindness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Lim, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, Nils Hasselmo Hall, 6-105
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
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