Voice Therapy for Teachers With Voice Problems

NCT ID: NCT00222937

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2010-08-31

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).

Conditions

Phonotrauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

A

Patients are enrolled in Lessac-Madsen Resonant Voice Therapy.

Group Type: EXPERIMENTAL

Lessac-Madsen Resonant Voice Therapy

Intervention Type: BEHAVIORAL

Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

B

Patients are enrolled in Casper Based Confidential Flow Therapy.

Group Type: EXPERIMENTAL

Casper-Based Confidential Flow Therapy

Intervention Type: BEHAVIORAL

Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

Interventions

Lessac-Madsen Resonant Voice Therapy

Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

Intervention Type: BEHAVIORAL

Casper-Based Confidential Flow Therapy

Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

Intervention Type: BEHAVIORAL

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
• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Kittie Verdolini Abbott

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Verdolini, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Clark Rosen, M.D.

Role: STUDY_DIRECTOR

University of Pittsburgh

Jackie Gartner-Schmidt, Ph.D.

Role: STUDY_DIRECTOR

University of Pittsburgh

Franca Benedicty Barton, M.S.

Role: STUDY_DIRECTOR

The Emmes Company, LLC

Locations

Massachusetts Eye & Ear Infirmary, Voice and Speech Laboratory

Boston, Massachusetts, United States

University of Pittsburgh Medical Center, Voice Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

#0304044

Identifier Type: -

Identifier Source: org_study_id