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

NCT ID: NCT03638986

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus, Subjective

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Swiss version first

This group will first complete the Swiss version and second the German version of the TFI

No intervention planned

Intervention Type OTHER

No Intervention planned.

German version first

This group will first complete the German version and second the Swiss version of the TFI

No intervention planned

Intervention Type OTHER

No Intervention planned.

Interventions

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No intervention planned

No Intervention planned.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Universityhospital Zurich, ENT Department

Locations

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Universitätsmedizin Berlin, Tinnituszentrum der Charité

Berlin, , Germany

Site Status

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Germany Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 22156949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28476163 (View on PubMed)

Bruggemann 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.

Reference Type BACKGROUND
PMID: 28499301 (View on PubMed)

Other Identifiers

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TFI_GER

Identifier Type: -

Identifier Source: org_study_id