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Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy

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ClinicalTrials.gov Identifier: NCT02518425
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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

  1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),
  2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain Scale (GRBAS Scale),
  3. 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).

Condition or disease
Functional Voice Disorder

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Which Instrumental Acoustic Voice Parameters Indicate Vocal Improvement After Voice Therapy in Patients With Functional Dysphonia
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Voice Disorders




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with functional voice disorders
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518425


Locations
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Switzerland
Clinic for Otorhinolaryngology University Hospital Zurich
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Joerg E Bohlender, MD University Hospital Zurich, Department of Otorhinolaryngology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02518425    
Other Study ID Numbers: BJ_02_02_2015
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases