NCT02441348

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

May 11, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

May 6, 2015

Last Update Submit

January 4, 2019

Conditions

Keywords

Voice TherapyMuscle Tension DysphoniaLesions

Outcome Measures

Primary Outcomes (1)

  • Change in the Voice Handicap Index-10 (VHI-10)

    Baseline through completion of therapy; approximately 6-8 months

Study Arms (1)

CTT group

CTT will be initiated in a prospective fashion to study population

Behavioral: Conversation Training Therapy

Interventions

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

CTT group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with either muscle tension dysphonia (MTD) or vocal fold lesion who are candidates for voice therapy.

You may qualify if:

  • 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)

You may not qualify if:

  • age 61 or greater
  • under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amanda I Gillespie, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 12, 2015

Study Start

May 11, 2016

Primary Completion

September 1, 2018

Study Completion

September 27, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations