Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy

NCT02518425 | Completed DMC

• 1 other identifier: BJ_02_02_2015
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Voice Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Subjective voice symptoms

  Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)

• Perceptual voice symptoms

  Before (initial diagnosis) and after voice therapy, expected average of 11-20 weeks after initial diagnosis)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with functional voice disorders

You may qualify if:

• 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).

You may not qualify if:

• known neurologic and psychiatric disease,
• hearing disorder,
• surgery of the head and neck area or intubation (for any reason) in last 18 months.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Clinic for Otorhinolaryngology University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

• Joerg E Bohlender, MD

  University Hospital Zurich, Department of Otorhinolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: August 7, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

CH (1)