Muscle Tension DysphoniaNCT04764604
Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment
A study testing Acapella Choice and Tube-in-water in people with Muscle Tension Dysphonia and Vocal Fold Palsy, run by University College, London at 1 site in United Kingdom.
Trial summary
A feasibility study to identify the immediate effect on the voices of patients with voice disorders (muscle tension dysphonia, vocal fold palsy or presbylaryngis) produced by exercising with Acapella Choice as a form of semioccluded vocal tract exercise (SOVTE). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Muscle Tension Dysphonia, Vocal Fold Palsy, Vocal Cord Paralysis
- What is being tested?
- Acapella Choice and Tube-in-water
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2020to 29 Nov 2021
- Phase
- Interventional
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand written English without the need for an interpreter,
- No diagnosed communication impairment
- Endoscopically confirmed primary ENT diagnosis of either:
- muscle tension dysphonia (with no laryngeal abnormality),
- Vocal fold palsy
- Presbylaryngis.
Who cannot join
- Previous SLT input
- Any of the following possible contraindications for PEP therapy:
- Inability to tolerate increased work of breathing,
- ICP (intracranial pressure) > 20mm Hg,
- Recent facial/oral/skull surgery or trauma,
- Oesophageal surgery,
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- Untreated pneumothorax,
- Known or suspected tympanic membrane rupture/other middle ear pathology,
- Haemodynamic instability,
- Acute sinusitis,
- Epistaxis,
- Active haemoptysis,
- Nausea
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National ENT Hospital, UCLH Hospitals NHS Trust
London, NW1 2PG
About this study
Official title: Evaluating the Therapeutic Use of a Vibratory Positive Expiratory Pressure Device (Acapella® Choice) in the Treatment of Pathological Voice - A Feasibility Study
A feasibility study to identify the immediate effect on the voices of patients with voice disorders (muscle tension dysphonia, vocal fold palsy or presbylaryngis) produced by exercising with Acapella Choice as a form of semioccluded vocal tract exercise (SOVTE).
Read the detailed description
This feasibility study is the natural extension of the researchers' recently completed study (R\&D 16/0242) which assessed how the use of an Acapella Choice (Smiths Medical) positive expiratory pressure (PEP) device as a semi-occluded vocal tract exercise (SOVTE) impacted acoustic, electroglottographic and aerodynamic measures of the voice in a group of normophonic volunteers. In that study, Acapella Choice was found to offer significantly greater oscillating intraoral pressures than techniques in current clinical practice and was found to have measurable benefits in terms of producing a louder and more economical voice. It offered the largest oscillating pressures, likened to a 'massage' of the vocal organs, giving it great therapeutic promise for patients with excess vocal tract tension.
This study seeks to evaluate the immediate effects of Acapella Choice as a voice exercise in patients with Muscle Tension Dysphonia, Presbylaryngis and Vocal Fold Palsy, and compare this to the widely-used voice rehabilitation technique of phonation into a tube held under water (henceforward referred to as "Tube"). Patients will be recruited from four weekly Voice Clinics held at the Royal National Throat Nose and Ear Hospital where their diagnosis will be confirmed. They will be invited to attend a single experimental session during which time they will exercise both with Acapella Choice and with Tube. Baseline and outcome voice measures will be taken and a short questionnaire will be completed, eliciting perceptions of the two exercises and any changes which were felt to have resulted from them.
The researchers' previous work suggests that Acapella Choice as a SOVTE may offer significant clinical benefits in terms of improved efficacy of therapy. It is suggested that it also offers patients a more convenient and user-friendly form of exercise which may well improve compliance and result in better outcomes.
- Being tested
- Acapella Choice, Tube-in-water
- Keywords
- semi-occluded vocal tract exercise, positive expiratory pressure, tube phonation, Acapella, voice therapy
- Medical subject headings
- Vocal Cord Paralysis, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella ChoiceDevice
Also called PEP, Semioccluded vocal tract exercise
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Tube-in-waterDevice
Also called Lax Vox, Resonance tube in water, Semi-occluded vocal tract exercise
3 minutes of exercise consisting of blowing through a silicone tube (10mm internal diameter) submerged in 5 cm of water whilst phonating at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Tension Group | Experimental | 10 participants with a diagnosis of muscle tension dysphonia will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions:
1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice
2. Three minutes of tube-in-water semi-occluded vocal tract exercise.
Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes.
Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention.
Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy. Receives: Device: Acapella Choice; Device: Tube-in-water |
| Vocal Fold Palsy Group | Experimental | 10 participants with a diagnosis of (unilateral) vocal fold palsy will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions:
1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice
2. Three minutes of tube-in-water semi-occluded vocal tract exercise.
Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes.
Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention.
Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy. Receives: Device: Acapella Choice; Device: Tube-in-water |
| Presbylaryngis Group | Experimental | 10 participants with a diagnosis of presbylaryngis will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions:
1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice
2. Three minutes of tube-in-water semi-occluded vocal tract exercise.
Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes.
Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention.
Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy. Receives: Device: Acapella Choice; Device: Tube-in-water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
A quantitative, multivariate, dysphonia summary tool that incorporates spectral (low/high spectral ratio) and cepstral measures (cepstral peak prominence), and their standard deviations, extracted from a continuous speech or sustained vowel sample utilising the software Analysis of Dysphonia in Speech and Voice (Kay Pentax, Montvale, NJ). The software calculates CSID on the scale of 0-100, whereby 0 represents no evidence of hoarse voice, and 100 represents a maximum amount of hoarseness. See: Awan SN, Roy N, Dromey C. Estimating dysphonia severity in continuous speech: Application of a multi-parameter spectralcepstral model estimating dysphonia severity in continuous speech. Clinical Linguistics and Phonetics. 2009;23(11):825-841. doi:10.3109/02699200903242988.
Measured: Immediately after 3 minutes of exercise
Secondary outcomes (7)
Change in Baseline Sound Pressure Level (dB)
Intensity of vocal signal
Measured: Immediately after 3 minutes of exercise
Change in Baseline Mean Contact Quotient
A percentage which illustrates the duration of vocal fold contact during one vocal fold period as measured by electroglottogram (EGG).
Measured: During 3 minutes of exercise (continual) and immediately following exercise.
Change in Subglottic Pressure
Measures of air pressure in the mouth.
Measured: During 3 minutes of exercise (continual)
Transglottic Airflow
Measures of flow of air through the vocal tract.
Measured: During 3 minutes of exercise (continual)
Change in Baseline Laryngeal Resistance
Derived from dividing mean intraoral pressure during /p/ by mean transglottic airflow during /a/ during a task which elicits repetition of 'pa-pa-pa-pa-pa'
Measured: Immediately after 3 minutes of exercise
Change in Baseline Perceptual Voice Quality
Expert ratings of overall voice quality using a simple ad-hoc 100mm visual analog scale (ranging from 0-100, reflecting a scale of normal voice quality to highly abnormal voice quality {higher numbers reflect more abnormality}).
Measured: Immediately after 3 minutes of exercise
Change in Baseline Participant Self-ratings - Voice Quality
Participant self-rating of voice quality (on a 100mm visual analog scale (0-100) where higher numbers reflect self-perception of better voice quality/ease of production)
Measured: Immediately after 3 minutes of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start14 Dec 2020
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Muscle Tension DysphoniaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a feasibility study using a 'before and after' design to test the immediate effects of exercising with Acapella Choice in comparison to the immediate effects of exercising with Tube-in-water resistance exercises (current treatment norm). Participants will be assigned groups according to their diagnosis (i.e. muscle tension group, vocal fold palsy group and presbylaryngis group). All participants will exercise with both techniques (i.e. Acapella and tube-in-water).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Smiths Medical, ASD, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian Saccente-Kennedy, MSc, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764604
- Sponsor's protocol ID
- 18/0434
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Titze IR, Story BH. Acoustic interactions of the voice source with the lower vocal tract. J Acoust Soc Am. 1997 Apr;101(4):2234-43. doi: 10.1121/1.418246.
PubMed 9104025Titze IR. Voice training and therapy with a semi-occluded vocal tract: rationale and scientific underpinnings. J Speech Lang Hear Res. 2006 Apr;49(2):448-59. doi: 10.1044/1092-4388(2006/035).
PubMed 16671856Sovijärvi A. Die Bestimmung der Stimmkategorien mittels Resonanzröhren. [Voice classification according to resonance tubes]. In: Fifth International Congress of Phonetic Sciences. Basel, NY. ; 1965.
Simberg S, Laine A. The resonance tube method in voice therapy: description and practical implementations. Logoped Phoniatr Vocol. 2007;32(4):165-70. doi: 10.1080/14015430701207790.
PubMed 17852715Enflo L, Sundberg J, Romedahl C, McAllister A. Effects on vocal fold collision and phonation threshold pressure of resonance tube phonation with tube end in water. J Speech Lang Hear Res. 2013 Oct;56(5):1530-8. doi: 10.1044/1092-4388(2013/12-0040). Epub 2013 Jul 9.
PubMed 23838993Granqvist S, Simberg S, Hertegard S, Holmqvist S, Larsson H, Lindestad PA, Sodersten M, Hammarberg B. Resonance tube phonation in water: High-speed imaging, electroglottographic and oral pressure observations of vocal fold vibrations--a pilot study. Logoped Phoniatr Vocol. 2015 Oct;40(3):113-21. doi: 10.3109/14015439.2014.913682. Epub 2014 May 28.
PubMed 24865620Wistbacka G, Sundberg J, Simberg S. Vertical laryngeal position and oral pressure variations during resonance tube phonation in water and in air. A pilot study. Logoped Phoniatr Vocol. 2016 Oct;41(3):117-23. doi: 10.3109/14015439.2015.1028101. Epub 2015 Jun 2.
PubMed 26033381Amarante Andrade P, Wistbacka G, Larsson H, Sodersten M, Hammarberg B, Simberg S, Svec JG, Granqvist S. The Flow and Pressure Relationships in Different Tubes Commonly Used for Semi-occluded Vocal Tract Exercises. J Voice. 2016 Jan;30(1):36-41. doi: 10.1016/j.jvoice.2015.02.004. Epub 2015 Apr 11.
PubMed 25873546Andrade PA, Wood G, Ratcliffe P, Epstein R, Pijper A, Svec JG. Electroglottographic study of seven semi-occluded exercises: LaxVox, straw, lip-trill, tongue-trill, humming, hand-over-mouth, and tongue-trill combined with hand-over-mouth. J Voice. 2014 Sep;28(5):589-95. doi: 10.1016/j.jvoice.2013.11.004. Epub 2014 Feb 20.
PubMed 24560003Guzman M, Castro C, Madrid S, Olavarria C, Leiva M, Munoz D, Jaramillo E, Laukkanen AM. Air Pressure and Contact Quotient Measures During Different Semioccluded Postures in Subjects With Different Voice Conditions. J Voice. 2016 Nov;30(6):759.e1-759.e10. doi: 10.1016/j.jvoice.2015.09.010. Epub 2016 Jun 13.
PubMed 26526005Radolf V, Laukkanen A, Horacek J, Liu D. In vivo measurements of air pressure, vocal folds vibration and acoustic characteristics of phonation into a straw and resonance tube used in vocal exercising. In: Proceedings of the 19th International Conference Engineering Mechanics, Czech Republic. ; 2013:478-483.
Awan SN, Gartner-Schmidt JL, Timmons LK, Gillespie AI. Effects of a Variably Occluded Face Mask on the Aerodynamic and Acoustic Characteristics of Connected Speech in Patients With and Without Voice Disorders. J Voice. 2019 Sep;33(5):809.e1-809.e10. doi: 10.1016/j.jvoice.2018.03.002. Epub 2018 Aug 3.
PubMed 30082107Guzman M, Calvache C, Romero L, Munoz D, Olavarria C, Madrid S, Leiva M, Bortnem C, Pino J. Do Different Semi-Occluded Voice Exercises Affect Vocal Fold Adduction Differently in Subjects Diagnosed with Hyperfunctional Dysphonia? Folia Phoniatr Logop. 2015;67(2):68-75. doi: 10.1159/000437353. Epub 2015 Sep 23.
PubMed 26394210Guzman M, Higueras D, Fincheira C, Munoz D, Guajardo C, Dowdall J. Immediate acoustic effects of straw phonation exercises in subjects with dysphonic voices. Logoped Phoniatr Vocol. 2013 Apr;38(1):35-45. doi: 10.3109/14015439.2012.731079. Epub 2013 Jan 28.
PubMed 23350916Guzman M, Laukkanen AM, Krupa P, Horacek J, Svec JG, Geneid A. Vocal tract and glottal function during and after vocal exercising with resonance tube and straw. J Voice. 2013 Jul;27(4):523.e19-34. doi: 10.1016/j.jvoice.2013.02.007. Epub 2013 May 15.
PubMed 23683806