Status:
COMPLETED
Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus.
Lead Sponsor:
CEN Biotech
Conditions:
Tinnitus
Eligibility:
All Genders
30-75 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05300594
Start Date
March 1 2022
End Date
June 5 2023
Last Update
December 26 2023
Active Locations (1)
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1
CEN Nutriment
Dijon, Bourgogne-Franche-Comté, France, 21000