Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05365126 |
| Other study ID # |
19ET004 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2022 |
| Est. completion date |
October 28, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Nottingham University Hospitals NHS Trust |
| Contact |
Julian A McGlashan, FRCS(Otol,) |
| Phone |
+44 7713093368 |
| Email |
julian.mcglashan[@]nottingham.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This proof-of-concept study is designed to evaluate whether a pedagogic technique used to
help performers, known as the Complete Vocal Technique (CVT), can be used to help patients
with a type of voice disorder known as Muscle Tension Dysphonia (MTD). MTD is responsible for
up to 40% of patients presenting with voice and throat complaints. MTD is due to inefficient
or ineffective voice production resulting from an imbalance in the control of the breathing
mechanism, and uncontrolled constriction of the muscles in the larynx (voice box) or vocal
tract (throat space above the vocal cords). Standard treatment is Voice Therapy delivered by
a specialist Speech Therapist (SLT-V) often using a video link (telepractice aka telehealth).
CVT is widely used in Europe by singers and vocal coaches. Practitioners (CVT- Ps) undergo a
three-year accredited training programme, and the systematic and structured approach helps
healthy singers and other performers optimise the function of the voice to produce any sound
required. It also helps if the performer has vocal problems, which are also mainly due to
uncontrolled throat constrictions.
The purpose of this pilot study is to see if the CVT voice therapy approach (CVT-VT) can
help, and offers advantages, to standard SLT-V methods in the treatment of patients with MTD.
Ten adult patients will be recruited from the Voice clinic at Nottingham University Hospital.
Participants will have a multidimensional assessment using questionnaires, and voice
recordings and then receive up to 6 video sessions of CVT-VT delivered using a video link by
a CVT-P. The participants will then be reviewed back in clinic at 8 weeks and be reassessed,
using further questionnaires and analysis of the voice pre- and post-therapy recordings, to
evaluate the outcome of this treatment approach. Qualitative methodology will determine
whether CVT-VT offers any therapeutic advantages to existing SLT-VT treatment methods.
Description:
Voice problems (dysphonia) affect one in 13 adults annually, causes a major impact on quality
of life and livelihood and is a substantial healthcare burden. It is more common in women and
in those with vocally demanding professions and the elderly. Forty percent of patients
referred for assessment of a voice problem have Muscle Tension Dysphonia (MTD) as a cause
brought on by an imbalance of breathing mechanism and/or uncontrolled tightness of the
muscles of the voice box or throat. The main symptoms are hoarseness, abnormal pitch or
loudness, variability in quality or control of the voice, throat discomfort or difficulty in
using the voice such as being able to use a louder voice when needed, or a voice that
fatigues with use with a consequent impact on quality of life. Traditionally there are six
described recognisable patterns of MTD based on the presenting symptoms, voice quality and on
appearance of the larynx (voice box) on examination with a video camera. Three types (MTD
patterns I-III) are more related to ineffective voice use, also known as 'voice abuse' or
'voice misuse', while the other three types (MTD patterns IV-VI) have a predominantly
psychological basis.
In the United Kingdom (UK), patients with persistent or unexplained hoarseness who are over
the age of 45 are referred under the two-week wait (2WW) cancer referral process. In other
cases, referral to an Ear, Nose and Throat (ENT) benign voice service is usually considered
if the dysphonia persists for more than six weeks, if it has not improved with simple
measures such as voice rest, reducing irritation to the vocal cords and drinking plenty of
fluids (known as vocal hygiene advice) or it is impacting significantly on the patient's work
or social life. In practice patients with MTD may come through both the 2WW and benign voice
pathways.
A diagnosis of MTD is made by an ENT surgeon and/or Speech & Language Therapist who has
specialised in voice disorders (SLT-V) based on the history of the vocal complaint and by
excluding an organic cause by examination of the patient's voice box (larynx) with a small
flexible video camera passed through the nose. Treatment is with voice therapy given by a
SLT-V. Voice therapy consists of two main types: Indirect Voice Therapy and Direct Voice
Therapy and is guided by advice from professional organisations such as Royal College of
Speech and Language Therapists Clinical Guidelines and the American Speech-Language-Hearing
Association (ASHA) Clinical Practice Guideline: hoarseness (dysphonia). Indirect therapy
consists of education, information, vocal hygiene, and stress management to encourage
behavioural change. Direct therapy consists of establishing healthy voice production by
rebalancing the three subsystems of voice production namely breathing (respiration), voice
production (phonation) and more efficient use of resonance.
The aim of voice therapy is generally to (a) return the patient's voice to normal or as best
as possible within the patient's anatomic and physiologic capabilities and (b) to satisfy the
patient's occupational, social and emotional vocal needs and (c) promote habit changes that
will ensure voice improvement will be maintained. Therapeutic goals should be specific and
determined by the patient prior to therapy to empower the patient in shared decision making
with the aim of improving motivation and compliance. In addition, the aim should be maximum
improvement in the minimum time.
MTD is a mixed group of conditions with different patterns of presentation and numerous
patient specific factors. In addition, Direct Voice Therapy is not just one treatment method
and many SLT-Vs use a hierarchical approach, which focuses in the early stages on postural
and relaxation techniques, followed by breathing exercises, voicing and resonance work with
final consolidation and review. The techniques applied by a SLT-V are also dependent on
abnormal findings on clinical examination the training and experience of the therapist and
the response and engagement of the patient. Although having a large variety of techniques
that can be used which can be tailored to the individual, Voice therapy has been portrayed as
a "black box" and many recognised treatment regimens overlap in the treatment aims and
therapeutic goals. This makes it difficult to determine why patients improve, which therapy
tasks are most beneficial and for how long the tasks should be continued.
Another limitation of traditional Direct Voice Therapy can be that patients often have
difficulty transferring the voice improvement on sustained vowels and during therapy sessions
into conversational voice and day-to-day voice use. It is also recognised that patients do
not always complete the therapy sessions in up to 18-65% of cases. Numerous reasons have been
put forward for this, including clinician and clinic-related factors, gender, ethnicity, age,
employment and perceived vocal severity, complex laryngeal diagnoses, additional medical
problems, time commitment for treatment sessions or lack of rapid progress, adequate, if not
complete, improvement in symptoms or failure to achieve goals. There is greater treatment
satisfaction and likelihood of success if Direct Voice Therapy techniques are functionally
orientated and have a more meaningful effect on quality of life with an emphasis on carryover
activities into conversation so that it is more relevant to the patient's daily vocal
demands. There is also increasing recognition that a patient may require more than one
'voice' to addresses the changing vocal needs (e.g., quiet talking, talking over noise, and
yelling) in different environments.
Traditionally voice therapy has been given in a clinic environment face-to-face. However,
with the onset of the Coronavirus (COVID-19) pandemic, Voice Therapy has almost entirely been
given using telepractice via a video link. Prior to the COVID-19 pandemic, telepractice had
been used by Speech and Language therapists mostly for geographical reasons and difficulties
in patients' attending outpatient clinics. There are relatively few studies in its use for
voice disorders and most studies on effectiveness have involved small cohorts of patients
with a range of voice pathologies such as Parkinson's disease. There are few randomised
controlled studies comparing face-to-face versus Telepractice and only one study of MTD
patients using the same voice therapy technique (Flow phonation). This showed no significant
difference in outcome between the two methods of delivery. Disadvantages of telepractice for
voice therapy include generic problems with technology, patient environmental and cultural
considerations, some instructional and practical issues with an inability to deliver more
'hands-on' techniques such as laryngeal manipulation. The Complete Vocal Technique (CVT) is
pedagogic technique primarily used by singing teachers and vocal coaches to aid singers and
actors produce the vocal sound and function that the performer requires. It has been used for
over 35 years particularly in Europe and CVT practitioners (CVT-P) undergo an accredited
3-year training programme to achieve competency. It uses a hierarchical, systematic approach
with terminology that is clearly defined and supported with scientific characterisation. It
is based on four key building blocks enabling for example a singer to produce any vocal sound
required in a healthy manner and regardless of genre of music. The first building block in
CVT training is to ensure a healthy voice is produced by adopting the three overall
principles: adequate support for the voice, use of a degree of twang ('necessary twang') and
avoidance of jaw protrusion and tightening of the lips. Secondly one of four main vocal modes
(Neutral, Curbing, Overdrive and Edge) is chosen which provides a set up for the larynx
depending on the vocal requirement. These terms were introduced to avoid confusion with other
more frequently used singing terms which lack precise definition. The choice of mode is
determined by vocal demand (loudness, pitch range, vowel and genre 'norm' (vocal style) that
is required: Neutral relates to normal conversational voice while the Curbing is a medium
loud voice. Overdrive can be used for voice projection up to a shout loudness, while Edge can
be used for a yelling and screaming quality. It would be expected that training in Neutral
and Overdrive would allow good vocal function for most social situations for patients with
MTD. The third element is to adjust the degree of sound colour (from dark to light) mostly
achieved by lowering or raising the larynx and increasing or decreasing the pharyngeal space.
The fourth element is to add specific vocal effects such as vibrato, ornamentation,
distortion etc., which can be added once the first three have been achieved. In this way the
precise sound required by the singer can be fashioned in any style or genre of music. The
principles have been applied to training the speaking voice and provide a recipe for
producing any desired voice quality for any environmental situation. A similar approach, that
has not been widely adopted, has also been described whereby the aim is not to support the
production of 'one voice', as is frequently the case with traditional SLT-VT, but to provide
the patient with a range of 'new' voices to meet the patient's vocal needs.
Training programmes have been developed, using this methodology, to enable singers and
singing teachers to improve, achieve vocal goals and overcome technical issues many of which
are due to unintentional hyper-constrictive muscle activity within the larynx and vocal
tract. CVT has also been applied to problems with the professional speaking voice and can
help with reducing constriction and improved voice production and projection. Specific
elements of CVT have also been packaged together in what is termed CVT Voice Therapy
(CVT-VT). CVT-VT is used for singers and other performers presenting with acute vocal
problems leading to hoarseness or loss of voice when time is of the essence in getting a
vocalist back to professional voice use. Although widely used by CVT-Ps and published in
several books it has not been formally evaluated.
The application of telepractice during the COVID-19 pandemic has also become a necessity in
teaching singing and has been adopted by the Complete Vocal Institute (CVI) in Denmark where
almost all tuition is now delivered on-line. Informal feedback from singers has been positive
with many advantages (comfort of own home, reduction in cost, and no travel time) outweighing
the disadvantages (some technical issues with audio/connection). It is likely a complete
return to previous methods of delivery of SLT and CVT practice will not happen after the
COVID-19 pandemic with the adoption of the new methods of service delivery for both.
In conclusion, the rationale for this Proof-of Concept study is to see whether an established
pedagogic technique, CVT, which is used to train singers and performers with healthy voices
and restore the voice when not functioning, can be used to treat patients with MTD and
whether it offers advantages to traditional SLT-VT techniques. Many of the voice problems in
performers and patients are due to faulty technique of voice production and are therefore
similar to patients with MTD. In addition, the focus of CVT is not only to improve the voice
and vocal function by reducing unhealthy throat constrictions but also allowing patients to
develop the voice needed for the vocal requirement. Further, the terms and pedagogic process
used in CVT are well defined and the theoretical framework on which it is built has been
extensively investigated. The main questions are does it offer benefit, and how does it
differ, from traditional SLT-VT methods and could it be a useful additional tool for SLT-VTs
in the management of MTD?
