Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus. (TINNITY)

CEN Biotech

Status: Completed

Conditions: Tinnitus

Treatments: Dietary Supplement: Plant extracts, vitamins and mineral; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05300594

C1694

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Main Exclusion Criteria:

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Audistim

Experimental group

Description:

The participants ingest the experimental product every day for 3 months. The experimental product contains a combination of plant extracts, vitamins and trace elements presented in 2 formulas: a day tablet (to be swallowed in the morning) and a night tablet (to be swallowed in the evening before going to bed).

Treatment:

Dietary Supplement: Plant extracts, vitamins and mineral

Placebo

Placebo Comparator group

Description:

Participants ingest the placebo product every day for 3 months .The placebo is strictly identical in appearance to the experimental product and contains only excipients.

Treatment:

Dietary Supplement: Placebo