MedPath

Kalmeda Tinnitus Study

Not Applicable
Conditions
H93.1
Tinnitus
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
NameTimeMethod
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
NameTimeMethod
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.
© Copyright 2025. All Rights Reserved by MedPath