NCT03638986

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

August 13, 2018

Last Update Submit

November 5, 2020

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

  • Comparison of the TFI sumscore of both German versions

    TFI sumscore ranges from 0 to 100

    20 minutes

Secondary Outcomes (1)

  • Factor analysis of the two German TFI versions

    20 minutes

Study Arms (2)

Swiss version first

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

Other: 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

Interventions

No intervention plannedOTHER

No Intervention planned.

German version firstSwiss version first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with tinnitus

You may qualify if:

  • Electronic given informed consent
  • Older than 18 years
  • Existing tinnitus
  • Sufficient knowledge of the German language

You may not qualify if:

  • Insufficient knowledge of the German language
  • Impossibility to fulfill an online questionnaire due to cognitive or physical limitation
  • No tinnitus
  • Younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsmedizin Berlin, Tinnituszentrum der Charité

Berlin, Germany

Location

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 22156949BACKGROUND

  • 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.

    PMID: 28476163BACKGROUND

  • 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.

    PMID: 28499301BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Peter, MD

    Universityhospital Zurich, ENT Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 20, 2018

Study Start

November 1, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

CH(1)DE(1)