NCT01196611

Brief Summary

The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 30, 2017

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

September 3, 2010

Last Update Submit

March 28, 2017

Conditions

Keywords

Voice disordersVoice

Outcome Measures

Primary Outcomes (2)

  • Fiberoptic endoscopic evaluation

    One year

  • Score(CAPE_V); score(PPAV); score on acoustic analysis

    One year

Study Arms (2)

Function Voice Exercises

EXPERIMENTAL

Behavioral: Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.

Behavioral: Function Voice Exercises

Voice amplification

EXPERIMENTAL

Behavioral: Voice amplification Patients will use VA over a course of 6 weeks.

Behavioral: Voice Amplification

Interventions

Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.

Voice amplification

Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.

Function Voice Exercises

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female teacher
  • years old.
  • Full or part time elementary to middle school teacher ( Prefeitura Municipal de Belo Horizonte).
  • Minimum 20 hour weekly workload.
  • Medical reference to speech therapy due to behavioral dysphonia

You may not qualify if:

  • Physical education or daycare teachers.
  • Professional singers.
  • Neurological and/or psychiatric voice disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mara S Behlau, PhD

    Universidade Federal de São Paulo

    STUDY DIRECTOR
  • Arnaldo L Colombo, PhD

    Federal University of São Paulo

    STUDY DIRECTOR
  • Letícia C Teixeira, MsC

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR
  • Ana Cristina C Gama, D

    Federal University of Minas Gerais

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/PhD

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 8, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

March 1, 2013

Last Updated

March 30, 2017

Record last verified: 2010-09

Data Sharing

IPD Sharing
Will not share

The data of the participants are confidential

Locations