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Completed

NCT Number: NCT04764604

Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal National ENT Hospital, UCLH Hospitals NHS Trust

London, NW1 2PG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • Untreated pneumothorax,
  • Known or suspected tympanic membrane rupture/other middle ear pathology,
  • Haemodynamic instability,
  • Acute sinusitis,
  • Epistaxis,
  • Active haemoptysis,
  • Nausea

Treatment and study plan

Acapella Choice

Device

3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.

Other names: PEP, Semioccluded vocal tract exercise

Tube-in-water

Device

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 names: Lax Vox, Resonance tube in water, Semi-occluded vocal tract exercise

Primary outcomes

  1. Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)

    Time frame: Immediately after 3 minutes of exercise

    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.

Secondary outcomes

  1. Change in Baseline Sound Pressure Level (dB)

    Time frame: Immediately after 3 minutes of exercise

    Intensity of vocal signal

  2. Change in Baseline Mean Contact Quotient

    Time frame: During 3 minutes of exercise (continual) and immediately following exercise.

    A percentage which illustrates the duration of vocal fold contact during one vocal fold period as measured by electroglottogram (EGG).

  3. Change in Subglottic Pressure

    Time frame: During 3 minutes of exercise (continual)

    Measures of air pressure in the mouth.

  4. Transglottic Airflow

    Time frame: During 3 minutes of exercise (continual)

    Measures of flow of air through the vocal tract.

  5. Change in Baseline Laryngeal Resistance

    Time frame: Immediately after 3 minutes of exercise

    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'

  6. Change in Baseline Perceptual Voice Quality

    Time frame: Immediately after 3 minutes of exercise

    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}).

  7. Change in Baseline Participant Self-ratings - Voice Quality

    Time frame: Immediately after 3 minutes of exercise

    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)

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Smiths Medical, ASD, Inc.

Registry information

Official study title

Evaluating the Therapeutic Use of a Vibratory Positive Expiratory Pressure Device (Acapella® Choice) in the Treatment of Pathological Voice - A Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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