Back to resultsEffect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus. (TINNITY)
Primary Purpose
Tinnitus
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plant extracts, vitamins and mineral
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Tinnitus
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.
Sites / Locations
- CEN NutrimentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Audistim
Placebo
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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".
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.
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05300594
Brief Title
Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEN Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Audistim
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant extracts, vitamins and mineral
Other Intervention Name(s)
Audistim Day Night
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Day tablet every morning during 3 months : Excipients; Night tablet every evening during 3 months : Excipients
Primary Outcome Measure Information:
Title
Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months
Description
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".
Time Frame
at month 0 (at inclusion), at month 3 (after 3 months of supplementation)
Secondary Outcome Measure Information:
Title
Change from baseline Tinnitus Handicap Inventory (THI) score to 1 month
Description
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".
Time Frame
at month 0 (at inclusion), at month 1 (after one month of supplementation)
Title
Psycological Stress Measure scale (MSP-9)
Description
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.
Time Frame
at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Title
Pittsburgh sleep quality index
Description
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.
Time Frame
at month 0 (at inclusion), at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Title
Patient Global Impression of Improvement (PGII)
Description
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
Time Frame
at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Title
Clinical Global Impression of Improvement (CGI-I)
Description
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
Time Frame
at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent HERPIN
Phone
0380680506
Ext
+33
Email
florent.herpin@groupecen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine JUHEL
Facility Information:
Facility Name
CEN Nutriment
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent Herpin
Phone
+33 (0) 3 80 68 05 06
Email
florent.herpin@groupecen.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus.
We'll reach out to this number within 24 hrs