Voice Therapy for Teachers With Voice Problems
Efficacy of Voice Therapy for Phonotrauma in Teachers
1 other identifier
interventional
105
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2005
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJanuary 25, 2016
January 1, 2016
3.7 years
September 20, 2005
January 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on Voice Handicap Index (VHI)
one year
Secondary Outcomes (5)
Does LMRVT contribute to the actual acquisition of "resonant voice" in speech?
one year
Do LMRVT or CBCFT improve laryngeal appearance?
one year
Do LMRVT or CBCFT improve conversational voice quality?
one year
Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery?
one year
Do LMRVT or CBCFT reduce the number of workdays lost annually?
one year
Study Arms (2)
A
EXPERIMENTALPatients are enrolled in Lessac-Madsen Resonant Voice Therapy.
B
EXPERIMENTALPatients are enrolled in Casper Based Confidential Flow Therapy.
Interventions
Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
Eligibility Criteria
You may qualify if:
- Full or part time teacher including college professor, daycare and preschool
- 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
You may not qualify if:
- Known degenerative medical condition
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Massachusetts Eye & Ear Infirmary, Voice and Speech Laboratory
Boston, Massachusetts, 02114, United States
University of Pittsburgh Medical Center, Voice Center
Pittsburgh, Pennsylvania, 15219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2009
Study Completion
August 1, 2010
Last Updated
January 25, 2016
Record last verified: 2016-01