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

Tinnitus Clinical Trial

— TINNITY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300594
• Other study ID #: C1694
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 5, 2023

Study information

• Verified date: August 2023
• Source: CEN Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 5, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Dietary Supplement:
• Plant extracts, vitamins and mineral
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)
• Placebo
Day tablet every morning during 3 months : Excipients; Night tablet every evening during 3 months : Excipients

Locations

Country	Name	City	State
France	CEN Nutriment	Dijon	Bourgogne

Sponsors (1)

Lead Sponsor	Collaborator
CEN Biotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline Tinnitus Handicap Inventory (THI) score to 1 month	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 1 (after one month of supplementation)
Secondary	Psycological Stress Measure scale (MSP-9)	The scale, no matter how many items it contains, is composed of symptom-descriptors of affective, cognitive, behavioral and physical problems. The respondent indicates to what extent the items describe him for the last 4 or 5 days. Examples of items (from the 53-item version): "1- I am tense or tense, 2- I feel my throat tight or I have a dry mouth, 3- I take more two alcohol drinks a day". Response options range from 1 (=not at all) to 8 (=extremely).The authors argue that the 9-item version displays the same psychometric qualities of reliability and internal consistency (0.89) as the 49- and 25-item versions.	at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Secondary	Pittsburgh sleep quality index	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.; Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Secondary	Patient Global Impression of Improvement (PGII)	The Patient Global Imression of Improvement (PGI-I) is a 7 point scale that requires the patient to assess himself how his illness has improved or worsened relative to a baseline state at the beginning of the intervention. "Compared to your condition at baseline, your condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse	at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Secondary	Clinical Global Impression of Improvement (CGI-I)	The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention."Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse	at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)