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Clinical Trials/NCT00222937
NCT00222937
Completed
Phase 3

Efficacy of Voice Therapy for Phonotrauma in Teachers

University of Pittsburgh2 sites in 1 country105 target enrollmentOctober 2005
ConditionsPhonotrauma

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Phonotrauma
Sponsor
University of Pittsburgh
Enrollment
105
Locations
2
Primary Endpoint
Score on Voice Handicap Index (VHI)
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
August 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kittie Verdolini Abbott

Professor

University of Pittsburgh

Eligibility 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.

Outcomes

Primary Outcomes

Score on Voice Handicap Index (VHI)

Time Frame: one year

Secondary Outcomes

  • Do LMRVT or CBCFT improve conversational voice quality?(one year)
  • Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery?(one year)
  • 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 reduce the number of workdays lost annually?(one year)

Study Sites (2)

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