Vocal FatigueVFINCT03378609
Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)
A study testing Vocal Fatigue Index (VFI) in people with Vocal Fatigue, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Vocal Fatigue
- What is being tested?
- Vocal Fatigue Index (VFI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2018to 8 Mar 2023
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- voice disorder (all etiologies)
Who cannot join
- age < 18 Jahre
- current voice therapy
- psychological disease
- botox injection in the Larynx
- inability to independently fill out the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)"
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.
- Conditions
- Vocal Fatigue
- Being tested
- Vocal Fatigue Index (VFI)
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal Fatigue Index (VFI)Other
Also called Voice Handicap Index (VHI9i), Vocal Tract Discomfort Scale (VTD)
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
| Study group | Role | What they receive |
|---|---|---|
| Vocal Fatigue Index (VFI) | Other | Standardized Questionnaire assessing vocal fatigue Receives: Other: Vocal Fatigue Index (VFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Dec 2018
- Primary completion31 Dec 2022
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal FatigueStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378609
- Sponsor's protocol ID
- JB_2016-01511
- Acronym
- VFI
- Status last verified
- May 2024
- First submitted
- 14 Dec 2017
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)"
- ClinicalTrials.gov ID
- NCT03378609
- Acronym / sponsor ID
- VFI / JB_2016-01511
- Conditions
- Vocal Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 20 Dec 2017 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vocal Fatigue Index (VFI) | Other | Other: Vocal Fatigue Index (VFI)Standardized Questionnaire assessing vocal fatigue |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- voice disorder (all etiologies)
Key exclusion criteria (5 listed)
- age < 18 Jahre
- current voice therapy
- psychological disease
- botox injection in the Larynx
- inability to independently fill out the questionnaire
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 |
|---|---|---|
| Vocal Fatigue Index (VFI)Also: Voice Handicap Index (VHI9i), Vocal Tract Discomfort Scale (VTD)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 | Other | Vocal Fatigue Index (VFI) |
Primary outcome
Validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
Time frame: one day
testing validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
1 secondary outcome
Reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
Time frame: one day
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 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Vocal Fatigue
Active, not recruiting
Straw Phonation Exercise Program for Pitch Extension
Voice Fatigue, Voice Disorders
Not yet recruiting
"Effects of EMST and Triflo on Voice Parameters and Vocal Fatigue"
Voice Fatigue, Voice Disorder
Recruiting
Brain and Voice Signatures in Teachers
Voice Disorders, Voice Fatigue
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocal Fatigue Index (VFI) in people with Vocal Fatigue, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 5 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.