Voice DisordersNCT02441348
Efficacy of Conversation Training Therapy (CTT)
An observational study of Voice Disorders, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Voice Disorders
- What is being tested?
- Conversation Training Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2016to 27 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals diagnosed with either muscle tension dysphonia (MTD) or vocal fold lesion who are candidates for voice therapy.
Who may be able to join
- 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)
Who cannot join
- age 61 or greater
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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%.
- Conditions
- Voice Disorders
- Being tested
- Conversation Training Therapy
- Keywords
- Voice Therapy, Muscle Tension Dysphonia, Lesions
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversation Training TherapyBehavioural
Conversational speech as the primary focus of voice therapy in individuals with muscle tension dysphonia or vocal fold lesions.
| Study group | Role | What they receive |
|---|---|---|
| CTT group | CTT will be initiated in a prospective fashion to study population Receives: Behavioral: Conversation Training Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Voice Handicap Index-10 (VHI-10)
Measured: Baseline through completion of therapy; approximately 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start11 May 2016
- Primary completionSep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Gartner-Schmidt, University of Pittsburgh
- Investigators
- Amanda I Gillespie, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441348
- Sponsor's protocol ID
- PRO15030497
- Status last verified
- Jan 2019
- First submitted
- 6 May 2015
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Conversation Training Therapy (CTT)
- ClinicalTrials.gov ID
- NCT02441348
- Acronym / sponsor ID
- PRO15030497
- Conditions
- Voice Disorders
- Keywords
- Voice Therapy, Muscle Tension Dysphonia, Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTT group | – | Behavioral: Conversation Training TherapyCTT will be initiated in a prospective fashion to study population |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals diagnosed with either muscle tension dysphonia (MTD) or vocal fold lesion who are candidates for voice therapy.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- age 61 or greater
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversation Training TherapyConversational speech as the primary focus of voice therapy in individuals with muscle tension dysphonia or vocal fold lesions. | Behavioural | CTT group |
Primary outcome
Change in the Voice Handicap Index-10 (VHI-10)
Time frame: Baseline through completion of therapy; approximately 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda I Gillespie, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Disorders, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Voice Handicap Index-10 (VHI-10) (time frame: Baseline through completion of therapy; approximately 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.