Kalmeda Tinnitus Study
Not Applicable
- Conditions
- H93.1Tinnitus
- Registration Number
- DRKS00022973
- Lead Sponsor
- mynoise GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 187
Inclusion Criteria
Chronic tinnitus longer than 3 months
Exclusion Criteria
psychological diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome variable of the study is the total score of the tinnitus questionnaire by Göbel and Hiller. It is primarily used to assess the effectiveness of Kalmeda. The primary endpoint is defined as the tinnitus burden after three months.
- Secondary Outcome Measures
Name Time Method As secondary endpoints, the respective changes in tinnitus burden, depression tendency, stress experience and self-efficacy after 12 months (control group) or 9 months (intervention group) are selected.