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

NCT05300594 | Completed

• 1 other identifier: C1694
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months

  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".

  at month 0 (at inclusion), at month 3 (after 3 months of supplementation)

Secondary Outcomes (5)

• Change from baseline Tinnitus Handicap Inventory (THI) score to 1 month

  at month 0 (at inclusion), at month 1 (after one month of supplementation)

• 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)

• 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)

Study Arms (2)

Audistim

EXPERIMENTAL

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).

Dietary Supplement: Plant extracts, vitamins and mineral

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Plant extracts, vitamins and mineral DIETARY_SUPPLEMENT

Day tablet every day during 3 months : Magnesium (75 mg), Ginkgo Biloba extract (40 mg), hawthorn extract (37,5 mg), L-Theanin (50 mg) , Niacin (16mg), Quercetin (25mg), B12 Vitamin (2,5 µg), B6 Vitamin (1,4 mg), Thiamin (1,1 mg) Night tablet every evening during 3 months : Magnesium (37,5 mg), Ginkgo Biloba extract (40 mg), Eschscholzia californica extract (40 mg), Zinc (10 mg), Melatonin (1mg), Lemon balm extract (80 mg), Tryptocetyn (65 mg)

Also known as: Audistim Day Night

Audistim

Placebo DIETARY_SUPPLEMENT

Day tablet every morning during 3 months : Excipients; Night tablet every evening during 3 months : Excipients

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• CEN Biotech: lead

Study Sites (1)

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Plant Extracts; Vitamins; Minerals

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 29, 2022
• Study Start: March 1, 2022
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-08

Locations

FR (1)