TinnitusTINNITYNCT05300594
Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus.
A study testing Plant extracts, vitamins and mineral in people with Tinnitus, run by CEN Biotech at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Plant extracts, vitamins and mineral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Plant extracts, vitamins and mineral, Placebo
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant extracts, vitamins and mineralDietary supplement
Also called Audistim Day Night
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)
PlaceboDietary supplement
Day tablet every morning during 3 months : Excipients; Night tablet every evening during 3 months : Excipients
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
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".
Measured: at month 0 (at inclusion), at month 1 (after one month of supplementation)
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.
Measured: 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
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.
Measured: 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)
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
Measured: at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
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
Measured: at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Mar 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300594
- Sponsor's protocol ID
- C1694
- Acronym
- TINNITY
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05300594
- Acronym / sponsor ID
- TINNITY / C1694
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audistim | Experimental | Dietary Supplement: Plant extracts, vitamins and mineralThe 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). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants ingest the placebo product every day for 3 months .The placebo is strictly identical in appearance to the experimental product and contains only excipients. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- 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);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant extracts, vitamins and mineralAlso: Audistim Day NightDay 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) | Dietary supplement | Audistim |
| PlaceboDay tablet every morning during 3 months : Excipients; Night tablet every evening during 3 months : Excipients | Dietary supplement | Placebo |
Primary outcome
Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months
Time frame: at month 0 (at inclusion), at month 3 (after 3 months of supplementation)
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".
5 secondary outcomes
Change from baseline Tinnitus Handicap Inventory (THI) score to 1 month
Time frame: at month 0 (at inclusion), at month 1 (after one month of supplementation)
Psycological Stress Measure scale (MSP-9)
Time frame: 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
Time frame: 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)
Time frame: at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Clinical Global Impression of Improvement (CGI-I)
Time frame: at month 1 (after one month of supplementation), at month 3 (after 3 months of supplementation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant extracts, vitamins and mineral in people with Tinnitus, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Tinnitus Handicap Inventory (THI) score to 3 months (time frame: at month 0 (at inclusion), at month 3 (after 3 months of supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.