Voice Therapy for Teachers With Voice Problems

January 21, 2016 updated by: Kittie Verdolini Abbott, University of Pittsburgh

Efficacy of Voice Therapy for Phonotrauma in Teachers

The study compares two different forms of voice therapy, Lessac-Madsen Resonant Voice Therapy and Casper-Based Confidential Flow Therapy. The target population are teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Lessac-Madsen Resonant Voice Therapy (LMRVT) and Casper-Based Confidential Flow Therapy (CBCFT) are equally effective at improving vocal functioning in teachers with phonotrauma, as assessed by the Voice Handicap Index (VHI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye & Ear Infirmary, Voice and Speech Laboratory
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh Medical Center, Voice Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full or part time teacher including college professor, daycare and preschool
  • 21 years of age and older
  • Complaints of voice problems declared to be lasting continuously for one month or more
  • Any structural or functional change to the larynx that appears related to phonation,including bilateral or unilateral lesions (assuming normal overlying epithelium based on clinical examination), non-specific edema, or erythema that appear by clinical history related to phonation, or primary muscle tension dysphonia or other condition related to phonation without lesions
  • No concurrent ear, nose and/or throat diagnoses, e.g. acute allergies, except for chronic allergies, sinusitis, and laryngopharyngeal reflux disease (LPR)
  • No vocal fold hemorrhage
  • No known degenerative medical conditions (e.g., degenerative neuromuscular disease, malignant process undergoing treatment or with less than 5 years remission, uncontrolled systemic disease (e.g., auto immune disease, or hormonal condition)
  • Normal hearing to 30 dB at 1000Hz - 3000Hz in the better ear
  • The participant is able to start therapy within 6 weeks of the initial evaluation and can be scheduled for 8 sessions (two per visit) in a 6-week time period
  • Agreement by the participant to provide information regarding days missed from work during the previous year and the year following treatment

Exclusion Criteria:

  • Known degenerative medical condition
  • Concurrent ear-nose-throat diagnosis, e.g., acute allergies (but chronic allergies, sinusitis, and laryngopharyngeal reflux disease (LPR) are not exclusion criteria) and vocal fold hemorrhage
  • Degenerative medical conditions that would exclude a participant from participation include, but are not limited to: degenerative neuromuscular disease, malignant process undergoing treatment or with less than 5 years remission, uncontrolled systemic disease (e.g. auto immune disease), or hormonal condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Patients are enrolled in Lessac-Madsen Resonant Voice Therapy.
Behavioral: Lessac-Madsen Resonant Voice Therapy
Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
Experimental: B
Patients are enrolled in Casper Based Confidential Flow Therapy.
Behavioral: Casper-Based Confidential Flow Therapy
Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on Voice Handicap Index (VHI)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Does LMRVT contribute to the actual acquisition of "resonant voice" in speech?
Time Frame: one year
one year
Do LMRVT or CBCFT improve laryngeal appearance?
Time Frame: one year
one year
Do LMRVT or CBCFT improve conversational voice quality?
Time Frame: one year
one year
Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery?
Time Frame: one year
one year
Do LMRVT or CBCFT reduce the number of workdays lost annually?
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Katherine Verdolini, Ph.D., University of Pittsburgh
  • Study Director: Clark Rosen, M.D., University of Pittsburgh
  • Study Director: Jackie Gartner-Schmidt, Ph.D., University of Pittsburgh
  • Study Director: Franca Benedicty Barton, M.S., The Emmes Company, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #0304044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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