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CompletedNCT03378609VFIUpdated May 16, 2024

Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)

An interventional study of Vocal Fatigue Index (VFI) in Vocal Fatigue, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by University of Zurich · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Vocal fatigue has been described as a common complaint in patients with voice disorders, however to date there is no standardized questionnaire in german language to assess specific symptoms. Main aim of this study is to assess the validity of the first german version of the Vocal Fatigue Index (VFI), and english questionnaire developed for voice patients to assess vocal fatigue.

In this study patients with voice disorders will receive the patient based questionnaires "Vocal Fatigue Index (VFI)", "Voice Handicap Index 9 international (VHI 9i)" and "Vocal Tract Discomfort Scale (VTD)", the study information and consent letter together with the standard invitation letter to a voice assessment at the Department for Phoniatrics and Speech Pathology University Hospital Zurich. Data of 93 consecutive volunteering patients will be collected. Furthermore a retest using the VFI will be conducted after 1 week with 10 volunteers. Thereafter construct validity of the VFI as compared to the established voice symptom questionnaires VHI 9i and VTD will be investigated. Further test-retest reliability will be determined.

02

Conditions studied

  • Vocal Fatigue

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03

In context

Voice Disorders

77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.

This study's enrollment of 81 is above the median of 41 across 54 interventional studies indexed under Voice Disorders.

Browse Voice Disorders studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age > 18 years
  • voice disorder (all etiologies)

Exclusion criteria

Exclusion Criteria:

  • age \< 18 Jahre
  • current voice therapy
  • psychological disease
  • botox injection in the Larynx
  • inability to independently fill out the questionnaire
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Other
    Vocal Fatigue Index (VFI)

    Standardized Questionnaire assessing vocal fatigue

    Other: Vocal Fatigue Index (VFI)

Interventions

  • OtherVocal Fatigue Index (VFI)

    collection of 190 consecutive data sets, participants give separate consent for participating a retest or an interview, retest will be realised with the 10 following volunteers

    Also known as: Voice Handicap Index (VHI9i), Vocal Tract Discomfort Scale (VTD)

06

What researchers measure

Primary outcomes

  1. Validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD

    testing validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD

    Time frame: one day

Secondary outcomes

  1. Reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD

    testing reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD

    Time frame: one day

07

Study locations

1 site
  • ORL Klinik
    Zürich, 8091, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Dec 2022, 48 months.

Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 48 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2017
First posted
Dec 20, 2017
StartActual
Dec 1, 2018
Primary completionActual
Dec 31, 2022
CompletionActual
Mar 8, 2023
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03378609
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Dec 1, 2018
Primary completion
Dec 31, 2022
Completion
Mar 8, 2023
Last update
May 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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