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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03638986
Other study ID # TFI_GER
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date August 1, 2020

Study information

Verified date November 2020
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Tinnitus is defined as a perception of sound without any external sound source. Chronic tinnitus is a frequent condition that can affect the quality of life. The questionnaire "Tinnitus Functional Index (TFI)" promises to be the new gold standard in tinnitus evaluation. Due to the forward and backward translation of this questionnaire, there are two different German versions of TFI for Switzerland and Germany. Both German versions were validated. The aim of this study is to compare the two German versions of the TFI with each other and to recommend the better one for the further use in tinnitus evaluation for the German speaking population.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date August 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Electronic given informed consent - Older than 18 years - Existing tinnitus - Sufficient knowledge of the German language Exclusion Criteria: - Insufficient knowledge of the German language - Impossibility to fulfill an online questionnaire due to cognitive or physical limitation - No tinnitus - Younger than 18 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention planned
No Intervention planned.

Locations

Country Name City State
Germany Universitätsmedizin Berlin, Tinnituszentrum der Charité Berlin
Switzerland University Hospital Zurich Zürich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (3)

Brüggemann P, Szczepek AJ, Kleinjung T, Ojo M, Mazurek B. [Validation of the German Version of Tinnitus Functional Index (TFI)]. Laryngorhinootologie. 2017 Sep;96(9):615-619. doi: 10.1055/s-0042-122342. Epub 2017 May 12. German. — View Citation

Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0. Erratum in: Ear Hear. 2012 May;33(3):443. — View Citation

Peter N, Kleinjung T, Jeker R, Meyer M, Klaghofer R, Weidt S. Tinnitus functional index: validation of the German version for Switzerland. Health Qual Life Outcomes. 2017 May 5;15(1):94. doi: 10.1186/s12955-017-0669-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the TFI sumscore of both German versions TFI sumscore ranges from 0 to 100 20 minutes
Secondary Factor analysis of the two German TFI versions 20 minutes
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