Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy

Functional Voice Disorder Clinical Trial

Official title:

Which Instrumental Acoustic Voice Parameters Indicate Vocal Improvement After Voice Therapy in Patients With Functional Dysphonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518425
• Other study ID #: BJ_02_02_2015
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: May 13, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Functional Voice Disorder
• Voice Disorders

Locations

Country	Name	City	State
Switzerland	Clinic for Otorhinolaryngology University Hospital Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instrumental acoustic voice parameters	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)	No
Secondary	Subjective voice symptoms	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)	No
Secondary	Perceptual voice symptoms	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)	No