We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Voice Therapy for Teachers With Voice Problems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222937
First Posted: September 22, 2005
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kittie Verdolini Abbott, University of Pittsburgh
  Purpose
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).

Condition Intervention Phase
Phonotrauma Behavioral: Lessac-Madsen Resonant Voice Therapy Behavioral: Casper-Based Confidential Flow Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Efficacy of Voice Therapy for Phonotrauma in Teachers

Resource links provided by NLM:


Further study details as provided by Kittie Verdolini Abbott, University of Pittsburgh:

Primary Outcome Measures:
  • Score on Voice Handicap Index (VHI) [ Time Frame: one year ]

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

Enrollment: 105
Study Start Date: October 2005
Study Completion Date: August 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222937


Locations
United States, Massachusetts
Massachusetts Eye & Ear Infirmary, Voice and Speech Laboratory
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh Medical Center, Voice Center
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
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 Corporation
  More Information

Responsible Party: Kittie Verdolini Abbott, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222937     History of Changes
Other Study ID Numbers: #0304044
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Kittie Verdolini Abbott, University of Pittsburgh:
Voice Problems
Voice Disorders


To Top