Double-blind Randomized Control Trial Versus Placebo to Assess the Daily Consumption Audistim® Day/Night on Hearing Comfort and Quality of Life of Patients With Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months
研究概览
简要总结
Tinnitus is a widespread problem that affects the quality of life of millions globally.
Few treatments have been found to be effective for subjective tinnitus and to have a significant improvement on quality of life. In subjective tinnitus, neither an external nor endogenous sound source is present; instead, the tinnitus is caused by abnormal bioelectric, biomechanical, or biochemical activity in the inner ear and/or central nervous system.
The precise role of the numerous extra-auditory structures that contribute to the pathophysiology of tinnitus is difficult to establish. Some of them participate in the creation or in the chronification of tinnitus and some in the psychological reactions to the tinnitus.
Audistim contains ingredients with a specific composition based upon the multifactorial causal theory; which involves auditory, attentional, memory, and emotional systems. These different systems are being targeted by the ingredients and their specific proportioning. Also the antioxidant theory is involved in the creation of Audistim, it states that the reactive oxygen species play an important microcirculatory role in the pathology of the inner ear and the peripheral and central pathways. These components help to treat the multitude of causing factors and in that way improve the quality of life.
详细描述
Participants are allocated in test (dietary supplement) or placebo group according a ratio 1:1.
The participants are asked to consume daily the investigational product for 3 months. The effect of the dietary supplement is assessed by comparing chronic tinnitus evolvement between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from subjective tinnitus for at least 6 months;
- •Tinnitus whose level of severity is defined by THI values ≥12 and ≤ 76;
- •Having given their written and informed consent to participate in the study.
排除标准
- •Severe Tinnitus (grade 5 corresponding to a THI ≥78);
- •Tinnitus with no or very slight impact on daily life (<2 out of a 10-point numerical scale);
- •Unilateral or bilateral cophosis;
- •Holder of an implant (cochlear, bone anchor);
- •Wearer of an airborne hearing aid for less than 6 months;
- •Suffering from hearing pathologies (Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma);
- •With otitis, earwax plug or damage to the eardrum inclusion;
- •Having started treatment with ototoxic drugs (anti-inflammatory, anti-coagulant, anti-arrhythmic, hypotensive, anti- depressants, MAOIs, Benzodiazepines, opioids) in the past 2 months;
- •Pharmacological treatment of tinnitus during the last 2 months;
- •Non-pharmacological treatments for tinnitus in the last 2 months: cognitive-behavioral therapy, habituation treatments or other therapies;
- •Taking food supplements containing one of the compounds of the product under study in the last month;
- •Known allergy to one of the compounds of the product under study;
- •Suffering from heart disease, hypertension, diabetes, autoimmune disease, inflammatory disease or pathology major or progressive;
- •Epileptic subject.
结局指标
主要结局
Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months
时间窗: at month 0 (at inclusion), at month 3 (after 3 months of supplementation)
THI is a widely used questionnaire to assess the severity of tinnitus. It is composed of 25 items in total, with functional (11 items), emotional (9 items), and catastrophic (5 items) subscales. Three response options (0=none, 2=sometimes, 4=always) are available for each item, and the total score is calculated by summing all responses. A total possible score of THI ranges from 0 to 100, and the higher score of THI represents greater handicap from tinnitus. The THI score of 0-16 means "no or slight handicap", 18 to 36 indicates "mild", 38 to 56 indicates "moderate", 58 to 76 indicates "severe", and a score of 78-100 is classified as "catastrophic handicap".
次要结局
- Psycological Stress Measure scale (MSP-9)(at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation))
- Pittsburgh sleep quality index(at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation))
- Change from baseline Tinnitus Handicap Inventory (THI) score to 1 month(at month 0 (at inclusion), at month 1 (after one month of supplementation))
- Patient Global Impression of Improvement (PGII)(at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation))
- Clinical Global Impression of Improvement (CGI-I)(at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation))