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Completed

NCT Number: NCT02518425

Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy

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).

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Key information

Conditions

Functional Voice Disorder

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Otorhinolaryngology University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2015
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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