Functional DysphoniaNCT02647840
The Effects of Voice Therapy Based on the Estill Voice Model: a Feasibility Study
A study testing voice therapy in people with Functional Dysphonia, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study wants to investigate treatment for patients with common voice disorders where no surgical or medical treatment is needed. A voice disorder is when your voice is croaky, hoarse or when you lose it altogether. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Functional Dysphonia
- What is being tested?
- voice therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 27 Apr 2017
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of muscle tension dysphonia or functional dysphonia
Who cannot join
- hearing problems, cognitive difficulties such as memory loss, and significant co-morbidities such as uncontrolled reflux or previous radiotherapy for Head \& Neck Cancer; significant psychological issues underlying the voice problem
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Speech and Language Therapy Department, Royal Devon and Exeter NHS Foundation Trust (Wonford)
Exeter, Devon
About this study
This study wants to investigate treatment for patients with common voice disorders where no surgical or medical treatment is needed. A voice disorder is when your voice is croaky, hoarse or when you lose it altogether. This can be a serious problem for people as it stops them from participating in their normal life (for example in their jobs, hobbies, family and wider social life).
This study will look at our most commonly used method of treatment for voice problems. This method is based on physical exercises which work on the muscles which produce the voice. This voice work was originally developed by Jo Estill, a singer and scientist, and is widely used in voice coaching. Though many Speech and Language Therapists (SLTs) provide voice therapy based on the Estill model, there is no clinical evidence to support its use.
Read more
The aim of this study is to test the design for a larger research study into the effects of voice therapy based on Estill model of voice. We want to find out if our tests work and are easy to use, and to check that the study methods are right and would work on a larger scale. It is a feasibility study, and therefore allows us to test whether this study can be done. Another important part of this study is to involve patients in developing research. We want to find out what patients think about the treatment they receive, and about taking part in a study.
The way this study will work is that patients who have agreed to take part will have between four and six voice therapy appointments, just like they would if they were not part of the study. Voice test results from before and after treatment will be compared and carefully studied. After patients taking part in the study have finished their treatment, they will be asked about their experience of voice therapy, and of being in the study. Much of what will be done as part of the study is identical to what is normally done in treatment, however we will look in detail at all the tests, and we need permission from participants to use their test results and include their comments.
It is important to learn more about voice therapy and to improve voice therapy for patients with this type of voice problem. By finding out more what patients think about the treatment we provide, what tests to use, and about how best to run a research trial, we will be able to plan further research and hopefully be successful at a next large research grant application.
Read the detailed description
Aims and Objectives The overall aim of this study is to test the feasibility of a study into the effects of Estill based voice therapy for patients with functional dysphonia.
The objectives are:
To gather information that will help us design a larger study, specifically
- how many participants can we expect to recruit
- what is the rate of consent
- what is the rate of attrition
- how many therapy sessions do patients attend over what length of time (length episode of care \& total therapy time in minutes) To test our outcome measures
- is using OperaVOX on iPad for clinical outcome measurement useful for clinician and participant; is it quick, easy to use, and reliable?
- what is the Standard Deviation (SD) for outcome measures so that we can estimate sample size for a further trial To describe therapy content in detail so that it can be replicated and meaningfully practised by participants
- what advice sheets/ therapy instructions do we give To investigate participant experience
- What is it like to have functional dysphonia
- What is it like to have voice therapy
- What is it like to take part in a study
- Does the overall design work smoothly for participants
- What worked well/ what could be better for participants Plan of investigation General research design This is a feasibility study using a mixed method research design. We will gain quantitative data from clinical voice assessments that will be analysed using descriptive statistics. We will also use qualitative research design when we use post-intervention focus groups to evaluate participants' experiences.
The study design does not control bias as it is not controlled and participants are not blinded to the intervention. We will therefore not be able to make a judgment as to whether Estill based voice therapy is effective in treating functional dysphonia in this study.
Study population The target population is adult patients referred into the SLT department by the Ear Nose Throat Consultant with a diagnosis of 'functional dysphonia', 'hyperfunctional dysphonia' or 'muscle tension dysphonia' and presenting with altered voice quality and essentially normal larynx on examination. Patients with a diagnosis of '(early) vocal nodules' and 'mild vocal oedema' may also be included as the underlying aetiology is inappropriate muscular tension and hyperfunction, and voice therapy the treatment of choice. Patients are aged 16 and above, and from Exeter, Mid and East Devon - the area normally served by the voice specialist service at the Royal Devon \& Exeter Foundation NHS Trust.
We plan to include 20 patients, as this sample size will be adequate for making accurate estimations of recruitment and judgements about outcome measures (including SD).
Patients with voice problems that indicate the presence of muscle tension and diagnoses specified above are eligible to take part. Patients with hearing problems, cognitive difficulties such as memory loss, and significant co-morbidities such as uncontrolled reflux or previous radiotherapy for Head \& Neck Cancer are excluded from the study, as these can limit expected progress. For the same reasons, patients with significant psychogenic issues underlying the voice problem will be excluded as they essentially have a diagnosis of psychogenic dysphonia. All patients not included in the study will be offered voice therapy as appropriate to their needs as usual.
Last year, 130 patients with functional dysphonia attended for voice therapy at the SLT department who would have been eligible to take part. It is estimated that it is feasible to recruit 20 participants over a six month period.
Potential participants will be identified on the basis of their referral letter from the ENT with diagnosis and presentation. When patients receive a standard letter inviting them to contact the SLT department for a voice therapy appointment, potentially eligible patients will receive an information leaflet about the study. On initial attendance at the SLT department, they will be given further information and a consent form to sign if they are happy to take part. It will be made clear that participants are free not to take part or to withdraw from the study at any time without it affecting their treatment in any way.
- Conditions
- Functional Dysphonia
- Being tested
- voice therapy
- Keywords
- dysphonia, voice therapy
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voice therapyBehavioural
Also called Estill voice model
voice therapy based on Estill Voice Model The study will provide primarily direct intervention, i.e. working directly on the voice with voice exercises based on the Estill model of voice. This will be structured and hierarchical. Participants will work through the content one-to-one with the voice specialist SLT at their level and pace, to suit their specific vocal needs, again reflecting current clinical practice. Participants may need fewer or more than four sessions to gain the required skills. Should patients need more than six session of voice therapy to recover their voice fully, final assessment for the study purposes will be taken at session 6, and voice therapy will continue as required.
| Study group | Role | What they receive |
|---|---|---|
| Voice therapy | Other | All participants will receive voice therapy based on the Estill model. This is very similar to our usual intervention. Receives: Behavioral: voice therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index 10
Patient report questionnaire (Using OperavOx app)
Measured: at initial and final assessment, before after therapy (approx 3 month interval)
Secondary outcomes (1)
Qualitative feedback
Feedback form participants about the therapy and study given to independent researcher in small group interview after therapy
Measured: after intervention, within 6 weeks of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMay 2016
- Primary completion28 Mar 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DysphoniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm P Hilton, MD, Study chair, Royal Devon and Exeter NHS TrustMarianne E Bos-Clark, MSc, Principal investigator, Royal Devon and Exter NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647840
- Sponsor's protocol ID
- 185519
- Status last verified
- Oct 2016
- First submitted
- 22 Dec 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Voice Therapy Based on the Estill Voice Model: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02647840
- Acronym / sponsor ID
- 185519
- Conditions
- Functional Dysphonia
- Keywords
- dysphonia, voice therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 6 Jan 2016 (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.
This study wants to investigate treatment for patients with common voice disorders where no surgical or medical treatment is needed. A voice disorder is when your voice is croaky, hoarse or when you lose it altogether. This can be a serious problem for people as it stops them from participating in their normal life (for example in their jobs, hobbies, family and wider social life).
This study will look at our most commonly used method of treatment for voice problems. This method is based on physical exercises which work on the muscles which produce the voice. This voice work was originally developed by Jo Estill, a singer and scientist, and is widely used in voice coaching. Though many Speech and Language Therapists (SLTs) provide voice therapy based on the Estill model, there is no clinical evidence to support its use.
The aim of this study is to test the design for a larger research study into the effects of voice therapy based on Estill model of voice. We want to find out if our tests work and are easy to use, and to check that the study methods are right and would work on a larger scale. It is a feasibility study, and therefore allows us to test whether this study can be done. Another important part of this study is to involve patients in developing research. We want to find out what patients think about the treatment they receive, and about taking part in a study.
The way this study will work is that patients who have agreed to take part will have between four and six voice therapy appointments, just like they would if they were not part of the study. Voice test results from before and after treatment will be compared and carefully studied. After patients taking part in the study have finished their treatment, they will be asked about their experience of voice therapy, and of being in the study. Much of what will be done as part of the study is identical to what is normally done in treatment, however we will look in detail at all the tests, and we need permission from participants to use their test results and include their comments.
It is important to learn more about voice therapy and to improve voice therapy for patients with this type of voice problem. By finding out more what patients think about the treatment we provide, what tests to use, and about how best to run a research trial, we will be able to plan further research and hopefully be successful at a next large research grant application.
Detailed description
Aims and Objectives The overall aim of this study is to test the feasibility of a study into the effects of Estill based voice therapy for patients with functional dysphonia.
The objectives are:
To gather information that will help us design a larger study, specifically
- how many participants can we expect to recruit
- what is the rate of consent
- what is the rate of attrition
- how many therapy sessions do patients attend over what length of time (length episode of care \& total therapy time in minutes) To test our outcome measures
- is using OperaVOX on iPad for clinical outcome measurement useful for clinician and participant; is it quick, easy to use, and reliable?
- what is the Standard Deviation (SD) for outcome measures so that we can estimate sample size for a further trial To describe therapy content in detail so that it can be replicated and meaningfully practised by participants
- what advice sheets/ therapy instructions do we give To investigate participant experience
- What is it like to have functional dysphonia
- What is it like to have voice therapy
- What is it like to take part in a study
- Does the overall design work smoothly for participants
- What worked well/ what could be better for participants Plan of investigation General research design This is a feasibility study using a mixed method research design. We will gain quantitative data from clinical voice assessments that will be analysed using descriptive statistics. We will also use qualitative research design when we use post-intervention focus groups to evaluate participants' experiences.
The study design does not control bias as it is not controlled and participants are not blinded to the intervention. We will therefore not be able to make a judgment as to whether Estill based voice therapy is effective in treating functional dysphonia in this study.
Study population The target population is adult patients referred into the SLT department by the Ear Nose Throat Consultant with a diagnosis of 'functional dysphonia', 'hyperfunctional dysphonia' or 'muscle tension dysphonia' and presenting with altered voice quality and essentially normal larynx on examination. Patients with a diagnosis of '(early) vocal nodules' and 'mild vocal oedema' may also be included as the underlying aetiology is inappropriate muscular tension and hyperfunction, and voice therapy the treatment of choice. Patients are aged 16 and above, and from Exeter, Mid and East Devon - the area normally served by the voice specialist service at the Royal Devon \& Exeter Foundation NHS Trust.
We plan to include 20 patients, as this sample size will be adequate for making accurate estimations of recruitment and judgements about outcome measures (including SD).
Patients with voice problems that indicate the presence of muscle tension and diagnoses specified above are eligible to take part. Patients with hearing problems, cognitive difficulties such as memory loss, and significant co-morbidities such as uncontrolled reflux or previous radiotherapy for Head \& Neck Cancer are excluded from the study, as these can limit expected progress. For the same reasons, patients with significant psychogenic issues underlying the voice problem will be excluded as they essentially have a diagnosis of psychogenic dysphonia. All patients not included in the study will be offered voice therapy as appropriate to their needs as usual.
Last year, 130 patients with functional dysphonia attended for voice therapy at the SLT department who would have been eligible to take part. It is estimated that it is feasible to recruit 20 participants over a six month period.
Potential participants will be identified on the basis of their referral letter from the ENT with diagnosis and presentation. When patients receive a standard letter inviting them to contact the SLT department for a voice therapy appointment, potentially eligible patients will receive an information leaflet about the study. On initial attendance at the SLT department, they will be given further information and a consent form to sign if they are happy to take part. It will be made clear that participants are free not to take part or to withdraw from the study at any time without it affecting their treatment in any way.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice therapy | Other | Behavioral: voice therapyAll participants will receive voice therapy based on the Estill model. This is very similar to our usual intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of muscle tension dysphonia or functional dysphonia
Key exclusion criteria (1 listed)
- hearing problems, cognitive difficulties such as memory loss, and significant co-morbidities such as uncontrolled reflux or previous radiotherapy for Head \& Neck Cancer; significant psychological issues underlying the voice problem
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 |
|---|---|---|
| voice therapyAlso: Estill voice modelvoice therapy based on Estill Voice Model The study will provide primarily direct intervention, i.e. working directly on the voice with voice exercises based on the Estill model of voice. This will be structured and hierarchical. Participants will work through the content one-to-one with the voice specialist SLT at their level and pace, to suit their specific vocal needs, again reflecting current clinical practice. Participants may need fewer or more than four sessions to gain the required skills. Should patients need more than six session of voice therapy to recover their voice fully, final assessment for the study purposes will be taken at session 6, and voice therapy will continue as required. | Behavioural | Voice therapy |
Primary outcome
Voice Handicap Index 10
Time frame: at initial and final assessment, before after therapy (approx 3 month interval)
Patient report questionnaire (Using OperavOx app)
1 secondary outcome
Qualitative feedback
Time frame: after intervention, within 6 weeks of discharge
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 21 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Malcolm P Hilton, MD study chair
Royal Devon and Exeter NHS Trust
Marianne E Bos-Clark, MSc principal investigator
Royal Devon and Exter NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing voice therapy in people with Functional Dysphonia, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 21 Aug 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 Kingdom. 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?
Voice Handicap Index 10 (time frame: at initial and final assessment, before after therapy (approx 3 month interval)). 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 21 Aug 2019.