Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Total Score on the Tinnitus Handicap Inventory (THI).
研究概览
简要总结
This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms
详细描述
The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subjective tinnitus
- •Tonal tinnitus.
- •Constant tinnitus on-going at least half the time over at least the past 6 months.
- •Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration.
- •Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation.
- •18 years of age or older
- •Primary language is English
排除标准
- •Objective tinnitus
- •Atonal, pulsatile, intermittent, or occasional tinnitus
- •Severe or profound hearing loss in one or both ears
- •Current or prior surgically removed acoustic neuroma
- •Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days:
- •NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other "loop" diuretics "mycin" antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin
- •Acute or chronic vertigo/dizziness
- •Ménière's disease
- •Prior stapendectomy
- •Prior mastoidectomy
- •Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past
- •Active infection/wound/external trauma to the areas to be treated with the laser
- •Medical, physical or other contraindications for, or sensitivity to, light therapy
- •Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
- •Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
结局指标
主要结局
Total Score on the Tinnitus Handicap Inventory (THI).
时间窗: Baseline and 8 week
The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual's life. Each question is responded to as 'yes' (4 points); 'sometimes' (2 points) or 'no' (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual's life. Change in total THI score is calculated as total THI score after the eight week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual's everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened).
次要结局
未报告次要终点