AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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,
Show all 13Show fewer
  • 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

Other trials in United Kingdom

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 groups in NCT04764604
Study groupRoleWhat they receive
Muscle Tension GroupExperimental10 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 GroupExperimental10 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 GroupExperimental10 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.

  1. 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)

  1. Change in Baseline Sound Pressure Level (dB)

    Intensity of vocal signal

    Measured: Immediately after 3 minutes of exercise

  2. 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.

  3. Change in Subglottic Pressure

    Measures of air pressure in the mouth.

    Measured: During 3 minutes of exercise (continual)

  4. Transglottic Airflow

    Measures of flow of air through the vocal tract.

    Measured: During 3 minutes of exercise (continual)

  5. 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

  6. 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

  7. 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.

  1. First posted21 Feb 2021
  2. Study start14 Dec 2020
  3. Primary completion29 Nov 2021
  4. Study completion29 Nov 2021

Resources

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)
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
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 9104025

  • Titze 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 16671856

  • Sovijärvi 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 17852715

  • Enflo 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 23838993

  • Granqvist 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 24865620

  • Wistbacka 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 26033381

  • Amarante 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 25873546

  • Andrade 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 24560003

  • Guzman 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 26526005

  • Radolf 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 30082107

  • Guzman 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 26394210

  • Guzman 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 23350916

  • Guzman 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

Questions about this trial

What is this clinical trial studying?

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.

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 6 inclusion and 13 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 1 Aug 2023. 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?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Baseline Cepstral/Spectral Index of Dysphonia (CSID) (time frame: Immediately after 3 minutes of exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04764604, which also lists 22 linked publications.

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 1 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in