Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05300594
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05300594
Study Brief:
Protocol Section:
NCT05300594