An Open Design Clinical Trial Investigating the Effect of Tinted Light on Perception of Tinnitus to Establish Its Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Averaged difference between dark and optimal tint tinnitus annoyance Visual Analogue Score (VAS)
研究概览
简要总结
Background
An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that viewing particular tints of light appeared to result in some improvement of their tinnitus.
This ameliorative effect appeared to be primarily acute and only reported to occur whilst viewing the tint. Individual patients would choose differing tints with some identifying more than one tint that affected their tinnitus.
Aim of the Study
In this current basic science study, the aim is to provide preliminary data to return estimates of the efficacy of using tinted light to ameliorate tinnitus.
After identification of responders during screening, responders are invited to attend three further trial sessions, where their tinnitus is assessed in response to three luminance conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light.
The response to low ambient light serves as a control to compare the effect of tinted light against and the response to white light serves as an 'active' stimulus comparator.
These results will then establish whether tinted light provides patients with a useful improvement in their tinnitus compared with measures of their baseline tinnitus obtained in the dark and against a standardised white light stimulus.
They will also inform further development of the technique as a potential treatment for tinnitus in responsive patients.
Over the three sessions, the averaged responses given by the patient under each stimulus condition will be analysed to provide a measure of efficacy.
详细描述
Study Protocol
The overall study design is open, as participants are explicitly required to identify a specific light tint that they perceive as affecting the annoyance or intrusiveness of their tinnitus. An element of an active control is provided by reference to changes reported with a self-selected tint referenced against white light. The a priori assumption is that with this optically defined white light, the reported changes in tinnitus will remain as zero. The following is a protocol outline of the trial as experienced by participants. All trial data is anonymised with hard copies securely held at the trial site.
Invitation to participate and seeking consent
First Visit:
Questionnaires and Screening for identifying Tinnitus patients reporting their whose perception of tinnitus is changed by tinted light .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 + years
- •Not receiving other tinnitus therapy or involved in any other tinnitus trial
- •To be in reasonable or good general health
- •Willing and able to give informed consent for participation in the study
- •Able to understand simple verbal explanation in English
- •Able to provide simple clear verbal feedback in English
排除标准
- •Aged under 18 yrs
- •Suffering only acute occasional tinnitus or non-intrusive tinnitus
- •Any serious illness that may adversely affect participation for example cancer, dementia/neurodegenerative illness, psychoses, stroke
- •Receiving other treatments for tinnitus during the trial
- •Unable or unwilling to give consent
- •Unable to understand or speak English
结局指标
主要结局
Averaged difference between dark and optimal tint tinnitus annoyance Visual Analogue Score (VAS)
时间窗: At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.
As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides tinnitus annoyance VAS values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light). At the end of each visit, the tinnitus annoyance VAS for the different visual stimulus conditions is then averaged. The difference between the averaged annoyance VAS for dark and the optimal light tint is calculated for each visit. After the final visit, the difference between the dark and optimal light tint conditions over all three visits is then averaged. This averaged difference in tinnitus annoyance over all three visits is then used as the primary outcome measure for the study.
次要结局
- Averaged difference between dark and optimal tint tinnitus loudness Visual Analogue Score (VAS)(At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.)