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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02441348
Other study ID # PRO15030497
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 11, 2016
Est. completion date September 27, 2018

Study information

Verified date January 2019
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Voice therapy is the standard-of-care for many of the nearly 140 million people in the United States who suffer from voice disorders,1 yet patients claim that current therapies are ineffective at meeting their voice needs.2 Published data by our research team indicate that patients think that transfer of target voice techniques to every day voice use (i.e. conversation) is the most difficult aspect of therapy,2 and that training techniques in conversation is the most useful aspect of voice therapy.2 Unfortunately, traditional voice therapy programs spend little, if any, time training voice techniques in conversation.3 This lack of functional specificity in voice therapy may contribute to the estimated 65% attrition rate.4 Even after some form of treatment, patients are still struggling with daily conversational voice use, and voice disorders continue to cause serious disability, stress and depression, which negatively affects social functioning and job performance.5 A new voice therapy program, Conversation Training Therapy (CTT), based on published patient reports on dissatisfaction with traditional therapy, was developed by the Investigators. It was honed with recommendations from expert clinical voice-specialized speech-language pathologists, and successfully piloted in a small case series of patients with voice problems. The investigators objective in this application is to test CTT in the rehabilitation of patients with voice disorders. The investigators hypothesize that, as demonstrated in the investigators preliminary case studies, these methods will result in early treatment success, and reduce the time required to reach therapeutic goals, thereby reducing costs associated with voice treatment.


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%.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date September 27, 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Conversation Training Therapy
Conversational speech as the primary focus of voice therapy in individuals with muscle tension dysphonia or vocal fold lesions.

Locations

Country Name City State
United States UPMC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Voice Handicap Index-10 (VHI-10) Baseline through completion of therapy; approximately 6-8 months
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