- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02441348
Efficacy of Conversation Training Therapy (CTT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two common voice disorders, vocal fold lesions (lesions) and muscle tension dysphonia (MTD) constitute over 60% of voice clinic caseloads. Over 80% of patients with lesions and nearly 100% of those with MTD are treated exclusively with voice therapy.7,8 Traditional, bottom-up hierarchical, non-conversation based voice therapy is the established standard of care used most widely by speech-language pathologists (SLP) in clinical practice.e.g.3,9,10 However, the investigators group's published research indicated a clear need to target conversational voice use in treatment.2 Currently, no treatment program exists with a focus on voice use in conversation. Most voice therapy techniques are based in hierarchical, programmatic approaches aimed at manipulating phonatory physiology for voice improvement. These hierarchies necessitate that the final step in therapy is generalization of the target voice techniques to spontaneous, conversational speech.3 Three major problems exist with this approach to voice therapy, which the current proposal aims to address.
First, A hierarchical non-conversational approach to therapy builds treatment from unvoiced breathing to single sounds and rote phrases to connected speech to spontaneous every day conversation last, if at all, and patients are often discharged from therapy unable to generalize therapy techniques to conversation. Second, the use of a hierarchical, bottom-up approach necessitates a protracted time in treatment. Third, attrition rates for behavioral voice therapy are estimated between 16-65%,4,17 and voice problem relapse rates are between 51-68%.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- males and females
- age 18-60 years old
- diagnosed by a multi-disciplinary team consisting of laryngologist and speech-language pathologist with muscle tension dysphonia (MTD) or vocal fold lesions deemed amenable to voice therapy (i.e. not surgical candidates) using a standardized stimulability test developed by the research team (in revision for publication)
Exclusion Criteria:
- age 61 or greater
- under 18 years of age
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CTT group
CTT will be initiated in a prospective fashion to study population
|
Conversational speech as the primary focus of voice therapy in individuals with muscle tension dysphonia or vocal fold lesions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the Voice Handicap Index-10 (VHI-10)
Time Frame: Baseline through completion of therapy; approximately 6-8 months
|
Baseline through completion of therapy; approximately 6-8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanda I Gillespie, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO15030497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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