Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

July 10, 2023 updated by: University College, London

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Royal National ENT Hospital, UCLH Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to understand written English without the need for an interpreter,
  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Acapella Choice
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
Device: 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 Names:
  • Lax Vox
  • Resonance tube in water
  • Semi-occluded vocal tract exercise
Experimental: 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.
Device: Acapella Choice
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
Device: 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 Names:
  • Lax Vox
  • Resonance tube in water
  • Semi-occluded vocal tract exercise
Experimental: 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.
Device: Acapella Choice
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
Device: 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 Names:
  • Lax Vox
  • Resonance tube in water
  • Semi-occluded vocal tract exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after 3 minutes of exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Sound Pressure Level (dB)
Time Frame: Immediately after 3 minutes of exercise
Intensity of vocal signal
Immediately after 3 minutes of exercise
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).
During 3 minutes of exercise (continual) and immediately following exercise.
Change in Subglottic Pressure
Time Frame: During 3 minutes of exercise (continual)
Measures of air pressure in the mouth.
During 3 minutes of exercise (continual)
Transglottic Airflow
Time Frame: During 3 minutes of exercise (continual)
Measures of flow of air through the vocal tract.
During 3 minutes of exercise (continual)
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'
Immediately after 3 minutes of exercise
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}).
Immediately after 3 minutes of exercise
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)
Immediately after 3 minutes of exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Smiths Medical, ASD, Inc.

Investigators

  • Principal Investigator: Brian Saccente-Kennedy, MSc, University College London Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Actual)

November 29, 2021

Study Completion (Actual)

November 29, 2021

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/0434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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