Clinical trial NCT05300594: Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months
timeFrame: at month 0 (at inclusion), at month 3 (after 3 months of supplementation)
Secondary outcomes:
measure: Change from baseline Tinnitus Handicap Inventory (THI) score to 1 month
timeFrame: at month 0 (at inclusion), at month 1 (after one month of supplementation)
measure: Psycological Stress Measure scale (MSP-9)
timeFrame: at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
measure: Pittsburgh sleep quality index
timeFrame: at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
measure: Patient Global Impression of Improvement (PGII)
timeFrame: at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Other outcomes:
Locations:
city: Dijon
country: France
facility: CEN Nutriment
state: Bourgogne
Study officials:
References: