NCT02409758

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

March 19, 2015

Last Update Submit

April 6, 2015

Conditions

Dysphonia

Keywords

Voice disordersHoarsenessTherapy

Outcome Measures

Primary Outcomes (1)

  • Improvement of the vocal quality (assessed by two self assessment questionnaires)

    The improvement was assessed by two questionnaires of self assessment vocal quality: Voice Related Quality of life questionnaire (VRQOL) and Voice Handicap Index (VHI) in the three different moments: pre therapy, post therapy and one month after therapy

    First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.

Secondary Outcomes (2)

  • Perceptual auditory analysis (assessed by 3 senior SLP)

    First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.

  • Improvement of larynx (evaluation by blind assessor)

    First assesment: in the beggining of the treatment; 2nd assesment: after 6 weeks of treatment; 3rd assesment: a month after the end of treatment.

Study Arms (2)

VFE voice therapy

ACTIVE COMPARATOR

Voice therapy: Vocal Function Exercises applied during 6 weeks

Behavioral: Voice therapy

CVRP voice therapy

EXPERIMENTAL

Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks

Behavioral: Voice therapy

Interventions

Voice therapyBEHAVIORAL

Voice therapy applied during 6 weeks.

Also known as: Voice treatment, SLP
CVRP voice therapyVFE voice therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • voice professionals with behavioral dysphonia, with or without larynx lesions, with otorhinolaryngologist's indication;
  • over 6 months with vocal complain;
  • or more signs and symptoms in the questionary.

You may not qualify if:

  • Other kind of vocal disorder, speech or language disorder, malignant lesions, hormonal disturbances related by the patient, laryngeal papilloma, etc.
  • Singers;
  • neurological problems;
  • acute larynx problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ziegler A, Gillespie AI, Abbott KV. Behavioral treatment of voice disorders in teachers. Folia Phoniatr Logop. 2010;62(1-2):9-23. doi: 10.1159/000239059. Epub 2010 Jan 8.

    PMID: 20093840BACKGROUND

  • MacKenzie K, Millar A, Wilson JA, Sellars C, Deary IJ. Is voice therapy an effective treatment for dysphonia? A randomised controlled trial. BMJ. 2001 Sep 22;323(7314):658-61. doi: 10.1136/bmj.323.7314.658.

    PMID: 11566828RESULT

  • Niebudek-Bogusz E, Sznurowska-Przygocka B, Fiszer M, Kotylo P, Sinkiewicz A, Modrzewska M, Sliwinska-Kowalska M. The effectiveness of voice therapy for teachers with dysphonia. Folia Phoniatr Logop. 2008;60(3):134-41. doi: 10.1159/000120290. Epub 2008 Mar 12.

    PMID: 18334848RESULT

MeSH Terms

Conditions

DysphoniaVoice DisordersHoarseness

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, Respiratory

Study Officials

  • Vanessa P Vieira, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 7, 2015

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

August 1, 2012

Last Updated

April 7, 2015

Record last verified: 2015-04