Tinnitus, SubjectiveNCT03638986
Comparison of the Two Validated German Versions of the "Tinnitus Functional Index" for Switzerland and for Germany
An observational study of Tinnitus, Subjective, run by University of Zurich at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective
- How many people
- 255 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2018to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with tinnitus
Who may be able to join
- Electronic given informed consent
- Older than 18 years
- Existing tinnitus
- Sufficient knowledge of the German language
Who cannot join
- Insufficient knowledge of the German language
- Impossibility to fulfill an online questionnaire due to cognitive or physical limitation
- No tinnitus
- Younger than 18 years
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- No intervention planned
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention plannedOther
No Intervention planned.
| Study group | Role | What they receive |
|---|---|---|
| Swiss version first | This group will first complete the Swiss version and second the German version of the TFI Receives: Other: No intervention planned | |
| German version first | This group will first complete the German version and second the Swiss version of the TFI Receives: Other: No intervention planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the TFI sumscore of both German versions
TFI sumscore ranges from 0 to 100
Measured: 20 minutes
Secondary outcomes (1)
Factor analysis of the two German TFI versions
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Nov 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Peter, MD, Principal investigator, Universityhospital Zurich, ENT Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638986
- Sponsor's protocol ID
- TFI_GER
- Status last verified
- Nov 2020
- First submitted
- 13 Aug 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22156949Peter 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.
PubMed 28476163Bruggemann 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.
PubMed 28499301
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive Studie Zum Vergleich Der Beiden Validierten Deutschen Versionen Des "Tinnitus Functional Index" für Die Schweiz Und für Deutschland
- ClinicalTrials.gov ID
- NCT03638986
- Acronym / sponsor ID
- TFI_GER
- Conditions
- Tinnitus, Subjective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swiss version first | – | Other: No intervention plannedThis group will first complete the Swiss version and second the German version of the TFI |
| German version first | – | Other: No intervention plannedThis group will first complete the German version and second the Swiss version of the TFI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tinnitus
Key inclusion criteria (4 listed)
- Electronic given informed consent
- Older than 18 years
- Existing tinnitus
- Sufficient knowledge of the German language
Key exclusion criteria (4 listed)
- Insufficient knowledge of the German language
- Impossibility to fulfill an online questionnaire due to cognitive or physical limitation
- No tinnitus
- Younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention plannedNo Intervention planned. | Other | German version first, Swiss version first |
Primary outcome
Comparison of the TFI sumscore of both German versions
Time frame: 20 minutes
TFI sumscore ranges from 0 to 100
1 secondary outcome
Factor analysis of the two German TFI versions
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 22156949Meikle 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.
- Background: PubMed 28476163Peter 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.
- Background: PubMed 28499301Bruggemann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Peter, MD principal investigator
Universityhospital Zurich, ENT Department
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, Subjective, run by University of Zurich at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the TFI sumscore of both German versions (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638986, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.