Comparison of the Two Validated German Versions of the "Tinnitus Functional Index" for Switzerland and for Germany

Tinnitus, Subjective Clinical Trial

Official title:

Prospektive Studie Zum Vergleich Der Beiden Validierten Deutschen Versionen Des "Tinnitus Functional Index" für Die Schweiz Und für Deutschland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638986
• Other study ID #: TFI_GER
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

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