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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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

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.




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


Secondary Outcome Measures :
  1. Factor analysis of the two German TFI versions [ Time Frame: 20 minutes ]


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

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
Publications:
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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