Voice Therapy for Teachers With Voice Problems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222937
First received: September 20, 2005
Last updated: December 8, 2009
Last verified: December 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Efficacy of Voice Therapy for Phonotrauma in Teachers

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Score on Voice Handicap Index (VHI) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does LMRVT contribute to the actual acquisition of "resonant voice" in speech? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Do LMRVT or CBCFT improve laryngeal appearance? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Do LMRVT or CBCFT improve conversational voice quality? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Do LMRVT or CBCFT reduce the number of workdays lost annually? [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: October 2005
Estimated Study Completion Date: June 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: Katherine Verdolini, Ph.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222937     History of Changes
Other Study ID Numbers: #0304044
Study First Received: September 20, 2005
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Voice Problems
Voice Disorders

Additional relevant MeSH terms:
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014