- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518425
Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy
May 13, 2016 updated by: University of Zurich
Which Instrumental Acoustic Voice Parameters Indicate Vocal Improvement After Voice Therapy in Patients With Functional Dysphonia
In a retrospective analysis of already existing clinical assessment data from patients with functional voice disorders the following aspects will be sampled, encoded and analysed: Outcomes pre and post treatment of
- subjective voice symptoms measured by Voice Handicap Index (VHI-9i),
- perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain Scale (GRBAS Scale),
- instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and range of speaking pitch and intensity, max. intensity and mean pitch of calling voice, singing voice: min./max. and range of pitch and intensity, maximum phonation time, Dysphonia Severity Index (DSI).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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ZH
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Zurich, ZH, Switzerland, 8091
- Clinic for Otorhinolaryngology University Hospital Zurich
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with functional voice disorders
Description
Inclusion Criteria:
- informed consent; patients 20 to 70 years with functional voice disorder; -diagnostics and voice therapy at University Hospital Zurich;
- full pre- and post treatment voice assessment (videostroboscopy, subjective self- assessment, instrumental acoustic and perceptual analysis).
Exclusion Criteria:
- known neurologic and psychiatric disease,
- hearing disorder,
- surgery of the head and neck area or intubation (for any reason) in last 18 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Instrumental acoustic voice parameters
Time Frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
|
Instrumental acoustic parameters are determined by a computer-assisted analysis of voice recordings.
In the present study the following parameters are measured before and after voice therapy: Jitter % (deviation of fundamental frequency), mean and range of speaking pitch and intensity, maximum intensity and mean pitch of calling voice, minimum and max.
and range of pitch and intensity of the singing voice, and the composite measure Dysphonia Severity Index (DSI).
|
Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective voice symptoms
Time Frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
|
Subjective voice symptoms are measured before and after voice therapy by the patient questionnaire "Voice Handicap Index" (VHI-9i).
|
Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
|
Perceptual voice symptoms
Time Frame: Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
|
Perceptual (hearable) voice symptoms are determined by the examiner before and after voice therapy using GRBAS Scale (Grading-Roughness-Breathiness-Asthenia-Strain Scale).
|
Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joerg E Bohlender, MD, University Hospital Zurich, Department of Otorhinolaryngology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 9, 2015
First Submitted That Met QC Criteria
August 4, 2015
First Posted (Estimate)
August 7, 2015
Study Record Updates
Last Update Posted (Estimate)
May 16, 2016
Last Update Submitted That Met QC Criteria
May 13, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJ_02_02_2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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