Clinical trial NCT00222937: Voice Therapy for Teachers With Voice Problems
Official title: Efficacy of Voice Therapy for Phonotrauma in Teachers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Phonotrauma
Keywords: Voice Problems
Voice Disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-22
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


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.

Primary outcomes:
measure: Score on Voice Handicap Index (VHI)
timeFrame: one year
Secondary outcomes:
measure: Does LMRVT contribute to the actual acquisition of "resonant voice" in speech?
timeFrame: one year
measure: Do LMRVT or CBCFT improve laryngeal appearance?
timeFrame: one year
measure: Do LMRVT or CBCFT improve conversational voice quality?
timeFrame: one year
measure: Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery?
timeFrame: one year
measure: Do LMRVT or CBCFT reduce the number of workdays lost annually?
timeFrame: one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye & Ear Infirmary, Voice and Speech Laboratory
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Voice Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Katherine Verdolini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Clark Rosen, M.D.
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh
name: Jackie Gartner-Schmidt, Ph.D.
role: STUDY_DIRECTOR
affiliation: The Emmes Company, LLC
name: Franca Benedicty Barton, M.S.
role: STUDY_DIRECTOR
References: