Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Tinnitus Rating (0-10, 10 being worst)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Characterization, Audiovisual
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.
干预措施: Tone (Other)
Characterization, Audiovisual
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.
干预措施: Video (Other)
结局指标
主要结局
Change in Tinnitus Rating (0-10, 10 being worst)
时间窗: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
the subject rates the disturbance or bothering nature of the tinnitus.
Change in Minimal Masking Level
时间窗: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
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.
次要结局
- Change in Tinnitus Subjective Description(Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm)
- Change in Tinnitus Functional Index Questionnaire Score(Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm)
- Change in Tinnitus Handicap Inventory Questionnaire Score(Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm)