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

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".

Time frame: 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.

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

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)

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

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)

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)