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

November 5, 2020 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with tinnitus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the TFI sumscore of both German versions
Time Frame: 20 minutes
TFI sumscore ranges from 0 to 100
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Factor analysis of the two German TFI versions
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFI_GER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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