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

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ClinicalTrials.gov Identifier: NCT03638986

Recruitment Status : Completed

First Posted : August 20, 2018

Last Update Posted : November 9, 2020

Sponsor:

Information provided by (Responsible Party):

University of Zurich

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Tinnitus, Subjective	Other: No intervention planned

Study Design

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Study Type :	Observational
Actual Enrollment :	255 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Prospektive Studie Zum Vergleich Der Beiden Validierten Deutschen Versionen Des "Tinnitus Functional Index" für Die Schweiz Und für Deutschland
Actual Study Start Date :	November 1, 2018
Actual Primary Completion Date :	August 1, 2020
Actual Study Completion Date :	August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Swiss version first This group will first complete the Swiss version and second the German version of the TFI	Other: No intervention planned No Intervention planned.
German version first This group will first complete the German version and second the Swiss version of the TFI	Other: No intervention planned No Intervention planned.

Outcome Measures

Primary Outcome Measures :

Comparison of the TFI sumscore of both German versions [ Time Frame: 20 minutes ]
TFI sumscore ranges from 0 to 100

Secondary Outcome Measures :

Factor analysis of the two German TFI versions [ Time Frame: 20 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Patients with tinnitus

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638986

Locations

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Germany
Universitätsmedizin Berlin, Tinnituszentrum der Charité
Berlin, Germany
Switzerland
University Hospital Zurich
Zürich, Zurich, Switzerland

Sponsors and Collaborators

University of Zurich

Investigators

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Principal Investigator:	Nicole Peter, MD	Universityhospital Zurich, ENT Department

More Information

Publications:

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.

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.

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.

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Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT03638986
Other Study ID Numbers:	TFI_GER
First Posted:	August 20, 2018 Key Record Dates
Last Update Posted:	November 9, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases	Sensation Disorders Neurologic Manifestations Nervous System Diseases

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