Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment
NCT ID: NCT04764604
Last Updated: 2023-08-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2020-12-14
2021-11-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management of Non-Organic Dysphonia in Adults.
NCT06856785
A Personalized Voice Restoration Device for Patients With Laryngectomy
NCT05479643
Movement of Epiglottis During Swallowing
NCT00475943
Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.
NCT02973152
Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
NCT06579989
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Muscle Tension Group
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.
Acapella Choice
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Tube-in-water
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.
Vocal Fold Palsy Group
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.
Acapella Choice
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Tube-in-water
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.
Presbylaryngis Group
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.
Acapella Choice
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Tube-in-water
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acapella Choice
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Tube-in-water
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No diagnosed communication impairment
* Endoscopically confirmed primary ENT diagnosis of either:
1. muscle tension dysphonia (with no laryngeal abnormality),
2. Vocal fold palsy
3. Presbylaryngis.
Exclusion Criteria
* 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,
* Untreated pneumothorax,
* Known or suspected tympanic membrane rupture/other middle ear pathology,
* Haemodynamic instability,
* Acute sinusitis,
* Epistaxis,
* Active haemoptysis,
* Nausea
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Smiths Medical, ASD, Inc.
INDUSTRY
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian Saccente-Kennedy, MSc
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal National ENT Hospital, UCLH Hospitals NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Gaskill CS, Erickson ML. The effect of a voiced lip trill on estimated glottal closed quotient. J Voice. 2008 Nov;22(6):634-43. doi: 10.1016/j.jvoice.2007.03.012. Epub 2007 Jun 15.
Gaskill CS, Quinney DM. The effect of resonance tubes on glottal contact quotient with and without task instruction: a comparison of trained and untrained voices. J Voice. 2012 May;26(3):e79-93. doi: 10.1016/j.jvoice.2011.03.003. Epub 2011 May 7.
Gaskill CS, Erickson ML. The effect of an artificially lengthened vocal tract on estimated glottal contact quotient in untrained male voices. J Voice. 2010 Jan;24(1):57-71. doi: 10.1016/j.jvoice.2008.05.004. Epub 2009 Jan 9.
Guzman M, Castro C, Testart A, Munoz D, Gerhard J. Laryngeal and pharyngeal activity during semioccluded vocal tract postures in subjects diagnosed with hyperfunctional dysphonia. J Voice. 2013 Nov;27(6):709-16. doi: 10.1016/j.jvoice.2013.05.007. Epub 2013 Sep 26.
Vampola T, Laukkanen AM, Horacek J, Svec JG. Vocal tract changes caused by phonation into a tube: a case study using computer tomography and finite-element modeling. J Acoust Soc Am. 2011 Jan;129(1):310-5. doi: 10.1121/1.3506347.
Patterson JE, Hewitt O, Kent L, Bradbury I, Elborn JS, Bradley JM. Acapella versus 'usual airway clearance' during acute exacerbation in bronchiectasis: a randomized crossover trial. Chron Respir Dis. 2007;4(2):67-74. doi: 10.1177/1479972306075483.
Mueller G, Bersch-Porada I, Koch-Borner S, Raab AM, Jonker M, Baumberger M, Michel F. Laboratory evaluation of four different devices for secretion mobilization: Acapella choice, green and blue versus water bottle. Respir Care. 2014 May;59(5):673-7. doi: 10.4187/respcare.02654. Epub 2013 Sep 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18/0434
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.