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Voice Therapy for Teachers With Voice Problems

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.
 
ClinicalTrials.gov Identifier: NCT00222937
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kittie Verdolini Abbott, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 25, 2016
Study Start Date  ICMJE October 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
Score on Voice Handicap Index (VHI) [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Score on Voice Handicap Index (VHI)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
  • Does LMRVT contribute to the actual acquisition of "resonant voice" in speech?
  • Does LMRVT improve laryngeal appearance?
  • Does LMRVT improve conversational voice quality?
  • Does LMRVT reduce the occurrence of laryngeal microsurgery?
  • Does LMRVT reduce the number of workdays lost annually?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Voice Therapy for Teachers With Voice Problems
Official Title  ICMJE Efficacy of Voice Therapy for Phonotrauma in Teachers
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Phonotrauma
Intervention  ICMJE
  • Behavioral: Lessac-Madsen Resonant Voice Therapy
    Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
  • Behavioral: Casper-Based Confidential Flow Therapy
    Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
Study Arms  ICMJE
  • Experimental: A
    Patients are enrolled in Lessac-Madsen Resonant Voice Therapy.
    Intervention: Behavioral: Lessac-Madsen Resonant Voice Therapy
  • Experimental: B
    Patients are enrolled in Casper Based Confidential Flow Therapy.
    Intervention: Behavioral: Casper-Based Confidential Flow Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2016)
105
Original Enrollment  ICMJE
 (submitted: September 20, 2005)
114
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222937
Other Study ID Numbers  ICMJE #0304044
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kittie Verdolini Abbott, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
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
PRS Account University of Pittsburgh
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP