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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03378609
Other study ID # JB_2016-01511
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date March 8, 2023

Study information

Verified date May 2024
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date March 8, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - age > 18 years - voice disorder (all etiologies) Exclusion Criteria: - age < 18 Jahre - current voice therapy - psychological disease - botox injection in the Larynx - inability to independently fill out the questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vocal 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

Locations

Country Name City State
Switzerland ORL Klinik Zürich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one day
Secondary 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 one day
See also
  Status Clinical Trial Phase
Completed NCT04486989 - Treatment for Teachers With Vocal Fatigue N/A